an investigation into mandatory newborn screening in new zealand
TRANSCRIPT
To Bleed or Not to Bleed?
An Investigation into Mandatory Newborn Screening in
New Zealand
Rachael Irvine
2006
A dissertation submitted for the degree of Bachelor of Laws (Honours)
Faculty of Law, University of Otago, Dunedin
I
Acknowledgements
I would like to sincerely thank the following people:
To my supervisor, Professor Nicola Peart. I have learnt an incredible amount while working
under you this year. Thank you for your thoughtful consideration of my topic, for challenging
me, and for the time and effort that you put into commenting on several of my earlier
‘attempts.’
To the staff of the Human Genome Research Project, especially Gen Matthews and Debbie
Lawson, for so willingly answering my questions and challenging my views on this topic.
Thank you also to Dianne Webster of the National Testing Centre, for showing an interest in
my topic and answering all my questions so thoroughly.
To my family, for diligent proofreading and providing all the necessary ‘supplies’ for
completing a dissertation. You have been incredibly supportive throughout my education and
I would not have been successful without your help.
To Brendon and Hayley, for the hours spent proofreading and generally supporting me while I
completed this dissertation.
To the law tutors and other friends, for answering my silly questions and generally making
University an incredibly fun 5 years.
II
Table of Contents
ACKNOWLEDGEMENTS I
INTRODUCTION 1
CHAPTER ONE: THE SCREENING PROCESS IN NEW ZEALAND 3
1. INTRODUCTION 3 2. SCREENING 3 2.1. CRITERIA FOR SCREENING 3 3. DISORDERS CURRENTLY TESTED FOR 4 3.1 PHENYLKETONURIA 4 3.2 CONGENITAL HYPOTHYROIDISM 4 3.3 GALACTOSAEMIA 5 3.4 BIOTINIDASE DEFICIENCY 6 3.5 MAPLE SYRUP URINE DISEASE 6 3.6 CONGENITAL ADRENAL HYPERPLASIA 7 3.7 CYSTIC FIBROSIS 8 4. IMPACT OF NEW TECHNOLOGY 8 5. FALSE POSITIVE AND FALSE NEGATIVE RESULTS 9 6. CONCLUSION 9
CHAPTER TWO: THE COURT’S POWER TO CONSENT TO NEWBORN SCREENING 10
1. INTRODUCTION 10 2. JURISDICTION OF THE COURT 10 3. THE PARENTAL RIGHT TO GIVE INFORMED CONSENT ON BEHALF OF CHILDREN 11 3.1 LIMITATIONS ON THE PARENTAL RIGHT TO CONSENT 11 3.2 DUTIES OF PARENTS 12 4. USE OF THE GUARDIANSHIP JURISDICTION TO CONSENT TO NBS 13 4.1 DECISIONS REGARDING THE TESTING OF NEWBORNS 13 a) Newborn Screening in Ireland: North Western Health Board v W. (H.) 13 (b) HIV Diagnostic Testing: Re C (HIV Test) 16 (c) New Zealand: Health and Disability Commissioner (HDC) Decisions 17 4.2 CASES REGARDING THE MEDICAL TREATMENT OF CHILDREN GENERALLY 17 (a) Objective Medical Benefits 18 (b) Effectiveness of the Proposed Procedures 19 (c) Effect on the Family 20 (d) Conclusion 21 4.3 DNA TESTING CASES 21 (a) Conclusion 23 4.4 CONCLUSION: EXERCISE OF THE COURT’S GUARDIANSHIP JURISDICTION 23 5. PERSONAL LIABILITY OF PARENTS 23 5.1 CRIMINAL LIABILITY 23 (a) Is NBS a ‘necessary’? 24 (b) A Lawful Excuse 25 5.2 CIVIL LIABILITY OF PARENTS 25
III
CHAPTER THREE: MANDATORY NEWBORN SCREENING STATUTORY REGIME 27
1. INTRODUCTION 27 2. THE IMPORTANCE OF ADDRESSING THIS ISSUE NOW, NOT LATER 27 3. DEFINING A MANDATORY SCREENING PROGRAMME 28 3.1 MANDATORY SCREENING IN THE UNITED STATES OF AMERICA 28 3.2 A UNIQUE ALTERNATIVE: PLACING DUTIES ON BOTH PARENTS AND HEALTH PROVIDERS 30 4. GOALS OF A MANDATORY SCREENING PROGRAMME 31 5. FACTORS IN FAVOUR OF MANDATORY NEWBORN SCREENING 31 5.1 BENEFITS FOR THE CHILD 31 5.2 BENEFITS FOR THE FAMILY 32 5.3 REASONS OF THE STATE 32 (a) Policy Reasons 32 (b) Economic Considerations 32 5.4 CONCLUSION 33 6. REASONS AGAINST HAVING A MANDATORY SCHEME 33 6.1 NEW ZEALAND’S CURRENT COMPLIANCE RATE. 33 (a) Would Mandatory Screening Increase Coverage? 33 (b) Would More Affected Children Be Detected Early? 34 (c) Risk That Compliance Will Drop 34 (d) Conclusion: New Zealand’s Current Compliance Rate 36 6.2 RISKS FOR THE CHILD 36 (a) Parental Fear of Prosecution and Health Providers 36 (b) Let Sleeping Dogs Lie 36 6.3 RISKS FOR THE FAMILY 37 6.4 REASONS OF THE STATE 37 (a) Policy Reasons 37 (b) Economic Considerations 37 7. CONCLUSION 38
CHAPTER FOUR: IS NEWBORN SCREENING A ‘JUSTIFIED LIMITATION’? 39
1. INTRODUCTION 39 2. RIGHTS AND INTERESTS AT STAKE 39 2.1 RIGHTS OF THE CHILD 39 (a) The Right to Life and Adequate Health Care 39 (b) The Right to an Open Future 40 2.2 INTERESTS OF THE STATE 40 2.3 RIGHTS OF PARENTS AS GUARDIANS 40 (a) Right to Consent on Behalf of a Child 40 (b) Right not to know 41 3. WHAT IS A JUSTIFIED LIMITATION? 41 4. PREVIOUS STATUTORY INTERVENTION ON PARENTAL RIGHTS 42 5. COMPARISON OF NBS WITH OTHER STATUTORY LIMITATIONS 43 5.1 BENEFIT TO THE STATE AND INDIVIDUALS 43 5.2 USING THE ‘BLUNT INSTRUMENT’ OF THE LAW 44 (a) Variability of Risk Between Children 44 (b) False Positive Results 45 (c) Variation in Clinical Outcome 46 (d) Conclusion 47
IV
6. VACCINATIONS: AN EXAMPLE WHERE PARLIAMENT HAS NOT INTERVENED 47 7. GENERAL SLIPPERY SLOPE ARGUMENT 48 8. CONCLUSION 49
CONCLUSION 50
BIBLIOGRAPHY 51
APPENDIX ONE: TABLE OF DISORDERS TESTED FOR BY NEWBORN SCREENING IN
NEW ZEALAND 61
1
Introduction
New Zealand began screening newborns for phenylketonuria in 1969 using a test designed by
Robert Guthrie. 1 This test was developed because evidence indicated that several patients in
mental institutions across the United States of America (USA) suffered from the disorder.2
This screening programme has since grown. Newborns are now tested for seven inherited
metabolic disorders.3 It is set to be expanded further by the end of 2006.
The test requires a simple and minor intervention. A small blood sample is taken, by pricking
the heel with a small needle, between two and four days after birth.4 The test is commonly
referred to as the ‘Guthrie Test’ or ‘Guthrie Heel Prick,’ and the stored sample as a ‘Guthrie
Card’.5 They are more accurately called the newborn screening test (NBS test) and newborn
screening card (NBS card) and will be described as such in this dissertation.
The disorders screened for are all rare, but there are serious consequences if an affected child
does not receive early treatment.6 Most children will appear normal when born, making
clinical diagnosis difficult or impossible.7 NBS identifies affected children before symptoms
develop and irreversible damage is done.8 If detected early enough, treatment can prevent
death or serious mental and physical harm.
Given the significant benefits and minimal harm associated with NBS, it is important to ask,
should NBS be mandatory? This dissertation aims to answer this question. Chapter one
outlines the disorders currently screened for in New Zealand and why it is important that as
many children as possible are screened. New Zealand’s current NBS programme is
1 D Gareth Jones, Katie Elkin, “Guthrie Cards: Legal and Ethical Issues” (2000) 1(2) New Zealand Bioethics
Journal 22, 22. The first tests began in 1964. In 1969 the National Testing Centre began testing all newborns. 2 Robert Guthrie, Ada Susi, “A Simple Method for Detecting Phenylketonuria in Large Populations of Newborn Infants” (1963) 32 Pediatrics 338, 338. Tests using urine had been developed but had proved to be an unreliable screening tool. 3 Ministry of health website, National Screening Unit, Conditions Tested, online at http://www.moh.govt.nz/moh.nsf/238fd5fb4fd051844c256669006aed57/1cc77940747fe4a7cc2570c0000c061c?OpenDocument, updated 16 June 2006, accessed 4 October. All NBS cards are sent to Auckland hospital to be tested for these disorders. 4 Auckland District Health Board website, Newborn Services Clinical Guidelines, online at http://www.adhb.govt.nz/newborn/Guidelines/Nutrition/MetabolicScreening.htm, accessed 3 October 2006. 5 This is despite the fact that many countries actually use a different technique to the one designed by Robert Guthrie. Privacy Commissioner, Guthrie Tests, Privacy Commissioner, 2003, 2 online at, http://www.privacy.org.nz/library/guthrie-tests accessed 6 October 2006. 6 Luciana Lara dos Santos, et al “The Time has Come: A New Scene for PKU Treatment” (2006) 5(1) Genetics
and Molecular Research 33, 33. 7 American College of Medical Genetics, Newborn Screening Expert Group, Newborn Screening: Toward a
Uniform Screening Panel and System (Commissioned by the Maternal and Child Health Bureau, Health Resources and Services Administration, 2005), 14. 8 American College of Medical Genetics, Newborn Screening Expert Group, (2005), 14.
2
voluntary.9 Yet, 99% of 60,000 children born each year are tested.10 Chapters two through
four analyse whether parents should retain the right to refuse consent to NBS on their child’s
behalf.
The court has jurisdiction under the Care of Children Act 2004 to place a child under the
guardianship of the court.11 This jurisdiction has been used in New Zealand for the purpose of
consenting to medical treatment such as blood transfusions and chemotherapy. Chapter two
considers whether the court would use this jurisdiction to consent to NBS. This involves a
close analysis of New Zealand case law as well as relevant cases from England and Ireland.
Chapter three assesses whether it would be appropriate to make NBS mandatory by legislation.
Close analysis will be made of the form the legislation might take, the goals it must achieve,
and whether it could achieve these goals. Legislative provisions in the USA, where NBS is
largely mandatory, are considered as part of this assessment.
Chapter four examines whether mandatory NBS is a justified limitation on the rights of
parents, as guardians, to determine the upbringing of their child. NBS is compared to other
situations where parents’ rights are limited by statute, to determine whether mandatory NBS is
also a justified limitation.
There are also a number of issues surrounding the storage of NBS cards. Once the newborn
screening test is completed the samples are stored indefinitely.12 The cards can be returned on
request at any time, but this is not always clearly communicated to parents before screening.13
If NBS became mandatory, further analysis of this storage policy would be necessary. Long
term storage and use of NBS cards is outside the scope of this dissertation and is only noted as
an issue for further consideration.
9 Jones (2000), 22. 10 Ministry of Health website, National Screening Unit, Newborn Screening in New Zealand Today, online at http://www.moh.govt.nz/moh.nsf/238fd5fb4fd051844c256669006aed57/38a4fd0fef7aa870cc2570c0000bffef?OpenDocument, accessed 4 October 2006. 11 Sections 30, 31, and 33 Care of Children Act 2004. 12 Jones (2000), 22. 13 Privacy Commissioner (2003), 10. See also, National Testing Centre, Your Newborn Baby's Blood Test: Te
Whakamātau Toto O To Peepi Hōu, National Testing Centre, Ministry of Health, Auckland, 2004, online at file:///C:/Documents%20and%20Settings/Acer/My%20Documents/Dissertation/Chapter%20One/Newborn%20screening%20leaflet%20NZ.htm accessed 5 October 2006.
3
Chapter One: The Screening Process in New Zealand
1. Introduction
To understand the legal issues canvassed in this dissertation it is necessary to understand the
medical reasons for conducting NBS. This chapter will briefly outline the features of the
disorders currently tested for in New Zealand and the effect of early treatment made possible
by NBS. This will highlight the severity of the disorders and the dramatic difference in
outcome for children who are identified and treated early, compared with children who are
diagnosed clinically.
2. Screening
Screening is different to diagnostic testing. Screening involves offering testing to an
asymptomatic population, to identify those with a disorder before they present with symptoms
requiring treatment.14 Further tests are usually required to confirm a diagnosis. Diagnostic
tests are done to determine the cause of existing symptoms, after a patient approaches their
health provider.
2.1. Criteria for Screening
Guidelines developed by the World Health Organisation (WHO), often called the ‘Wilson-
Junger’ screening criteria, have been used internationally to determine which disorders should
be included in screening programmes. 15 The disorder should be well understood and an
‘important health problem.’ 16 It is not appropriate to screen unless early treatment is
advantageous to the patient.17 Therefore, the disorder must have a latent period and an
available treatment, which is effective during that period.18 The cost of screening must also be
balanced against the overall expenditure on medical care for that disorder.19 There is some
concern that not every disorder screened for in expanded NBS programmes meets these
criteria.20
14 Howard S Cuckle, and Nicholas Wald, “Tests Using Single Markers” in Nicholas Wald, and Ian Leck (eds), Antenatal and Neonatal Screening (2nd Ed., Oxford University Press, Oxford, 2000) 3, 3-4. 15 J M G Wilson, and G Junger, Principles and Practice of Screening for Disease, (World Health Organisation, Geneva, 1968) These criteria have been cited with support in a number of articles. See for example N J Kerruish, and S P Robertson, “Newborn Screening: New Developments, New Dilemmas” (2005) 31 Journal of Medical
Ethics 393. This article refers to the Wilson-Junger criteria as the gold standard in screening criteria. 16 Principles 1 and 7, Wilson (1968), 26-27. Defining an ‘important health problem’ requires analysis of several factors. For example, it may be appropriate to screen for a rare disease with severe consequences. 17 Wilson, (1968), 28. 18 Principles 2 and 4, Wilson (1968), 27 and 29. 19 Principle 9 Wilson (1968), 27 and 35-37. 20 Diane Paul, “Contesting Consent: The Challenge to Compulsory Neonatal Screening for PKU” (1999) 42(2) Perspectives in Biology and Medicine 207(1), 4. This author argues that the concepts of benefit and treatment have been widened to rationalise the inclusion of some tests in NBS programmes. This concern is discussed further in chapter four.
4
3. Disorders Currently Tested For21
3.1 Phenylketonuria
Phenylketonuria (PKU) affects 1 in 15,000 New Zealand newborns. 22 Patients have an
enzyme deficiency which means that they cannot metabolise phenylalanine, an essential
component of proteins.23 If left untreated, toxic levels of phenylalanine accumulate in the
blood, 24 causing severe and permanent mental retardation, seizures, and autistic like
behaviour.25 Clinical diagnosis is only possible once mental retardation is apparent, meaning
irreversible brain damage has already occurred.26 However, treatment started as soon as
possible after birth prevents this damage.27
PKU patients must follow a restrictive, low protein diet for life,28 avoiding dairy products,
meat, eggs, wheat, nuts, and some fruit and vegetables. 29 Because screening for PKU has
been so successful, very few untreated children are seen in clinical practice.30 NBS facilitates
early treatment, which has the power to prevent serious brain damage in children with PKU.
3.2 Congenital Hypothyroidism
Congenital Hypothyroidism (CH) is a disorder characterised by low levels of thyroid
hormone.31 It affects 1 in 4,500 newborns.32 Most babies with CH appear normal when
born. 33 If untreated, they progressively develop lethargy, hypothermia, growth failure,
deafness, mental retardation, and other neurological problems.34 Clinical diagnosis is not
possible until irreversible damage occurs.35 This damage can be prevented by taking daily
21 A summary of this information is included in a table as appendix one, for easy reference while reading other sections of this dissertation. 22 LabPLUS website, Auckland District Health Board, National Testing Centre, online at http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006. 23 George C Cunningham, “Phenylketonuria and Other Inherited Metabolic Defects” in Nicholas Wald, and Ian Leck (eds), Antenatal and Neonatal Screening (2nd Ed., Oxford University Press, Oxford, 2000) 353, 353. 24 Cunningham (2000), 353. 25 Committee on Genetics, “Newborn Screening Fact Sheets” (1996) 98 Pediatrics 473, 489-90. 26 Cunningham (2000), 353. Newborn babies can have eczema, growth retardation, an abnormally small head, very fair skin and hair, and experience vomiting. However, these symptoms are not specific to PKU. 27 Committee on Genetics (1996), 490. Children show normal growth patterns and IQ within the normal range. Some children suffer from minor conceptual and language problems which do not usually affect their social skills or ability to obtain employment in later life: Cunningham (2000), 363. 28 Cunningham (2000), 362; dos Santos (2006), 35. 29 dos Santos (2006), 35. 30 dos Santos (2006), 34 . 31 This can be caused by several different defects in the thyroid gland. Joseph G Hollowell, Bradford L Therrell, W Harry Hannon, “Congenital Hypothyroidism” in Wald, Nicholas, Leck Ian, (Eds) Antenatal and Neonatal
Screening, (2nd Ed., Oxford University Press, Oxford, 2000) 370 p370-372. 32 Lab plus website http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006. 33 Committee on Genetics (1996), 481. 34 The level of disability suffered is related to the length of time before proper treatment begins as well as the type of CH suffered from: Hollowell (2000), 372-73. 35 Clinical diagnosis is not usually possible until three to six months of age: Hollowell (2000), 370.
5
thyroid hormone supplements as soon as possible after birth.36 NBS can accurately detect CH
as early as 2-4 days after birth and is therefore an important tool for preventing mental
retardation and growth defects.37
3.3 Galactosaemia
Galactosaemia affects 1 in 120,000 newborns.38 Patients cannot metabolise galactose, formed
when milk is broken down in the body.39 Without early treatment this disorder is usually
fatal.40 Babies first present with feeding problems, lethargy, vomiting, diarrhoea, and reduced
muscle tone.41 If the child survives without treatment this soon leads to severe liver disease,
mental retardation, cataracts, and blood clotting problems.42 Galactosaemic infants are also
highly susceptible to E. Coli infections, which is a common cause of death in these children.43
Early treatment dramatically reduces the risk of death and prevents growth problems, liver
damage and cataracts.44 Galactosaemic patients follow a strict galactose free diet for life.45
Unfortunately, this cannot prevent all long term complications.46 Some patients have speech
and muscle coordination problems.47 Others show mental retardation of varying severity.48
NBS cannot prevent all harm but protects against many life-threatening risks for
galactosaemic patients.
36 In more severe cases some children still show minor problems with visual and spatial perception and motor movement in response to sensory information: Susan R Rose, et al “Update of Newborn Screening and Therapy for Congenital Hypothyroidism” (2006) 117 Pediatrics 2290, 2298-9. 37 Rose (2006), 2294. Samples taken before 48 hours will detect most types of CH but not all. 38 Lab plus website http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006. 39 Annet M Bosch, “Classical Galactosaemia Revisited” (2006) 29 Journal of Inherited Metabolic Disease 516, 516, 518. 40 Committee on Genetics (1996), 486. 41 Bosch (2006), 518. 42 J B Sidbury, “Investigations and Speculations on the Pathogenesis of Galactosemia” in David Yi-Yung Hsia (ed), Galactosemia (C.C. Thomas, Springfield, Illinois 1969) 13, 13. 43 Bosch (2006), 519. 44 Committee on Genetics (1996),486, G N Donnell, Richard Loch, and W R Bergen, “Observations on Results of Management of Galactosemic Patients” in David Yi-Yung Hsia, (ed), Galactosemia ( C.C. Thomas, Springfield, Illinois 1969) 247, 249. 45 Bosch (2006), 519. The diet is also lactose free as break down of lactose produces galactose. Other treatment such as antibiotics for E.Coli sepsis and treatment for liver damage may be needed early in life. 46 Bosch (2006), 519-20. The severity of the disorder seems to depend largely on the particular type of galactosaemia a patient suffers from. Long term harm is possibly caused by body producing its own galactose, which cannot be excluded by dietary restrictions. 47 M Bhat, C Haase, and P J Lee, “Social Outcome in Treated Individuals with Inherited Metabolic Disorders: UK Study” (2005) 28 Journal of Inherited Metabolic Disease 825, 829. 48 Committee on Genetics (1996), 486. IQ in galactosaemic patients is varied but usually below, or at the lower end, of normal. There is some evidence that neurological problems are related to time of treatment, so early treatment may still reduce intellectual impairment.
6
3.4 Biotinidase Deficiency
Biotinidase deficiency (BD) affects 1 in 50,000 newborns. 49 Patients have an enzyme
deficiency,50 which causes seizures, loss of muscle tone, skin rashes, hair loss, eyesight and
hearing loss, mental retardation, developmental delay,51 and acidosis which can lead to coma
and death. 52 Clinical diagnosis is only possible once these symptoms develop. 53 Early
treatment with daily biotin supplements prevents the onset of these symptoms.54 Treatment of
children at any stage leads to some clinical improvement,55 but eyesight and hearing loss, and
mental retardation are irreversible.56 NBS is important because it allows early treatment
before these symptoms develop.57
3.5 Maple Syrup Urine Disease
Maple Syrup Urine Disease (MSUD) affects 1 in 250,000 newborns.58 The disorder is caused
by an enzyme deficiency, which means patients cannot metabolise branched-chain amino
acids (BCAA), found in proteins.59 If untreated, MSUD leads to acidosis, lethargy, seizures,
brain dysfunction, coma and death.60 These symptoms develop rapidly during the first 2-4
days of life. 61 Children that survive without early treatment, suffer serious mental
retardation.62
49 Lab plus website http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006. 50 Patients have a defective biotinidase enzyme, which is needed to recycle biotin, a coenzyme in several important processes. The disorder presents in a variety of forms and severities: Dorothea Moslinger, et al, “Clinical and Neuropsychological Outcome in 33 Patients with Biotinidase Deficiency Ascertained by Nationwide Newborn Screening and Family Studies in Austria,” (2001) 160 European Journal of Pediatrics 277, 278. 51 Barry Wolf, et al, “Biotinidase Deficiency: Novel Mutations and Their Biochemical and Clinical Correlates,” (2005) 25(4) Human Mutation 413 (Wolf No2) ,2 Electronic article, numbered from page 1, online at http://www3.interscience.wiley.com/cgi-bin/abstract/11 0431219/ABSTRACT?CRETRY=1&SRETRY=0 accessed 6 October 2006. 52 Moslinger (2001), 278. Acidosis is an abnormal increase in the acidity of fluids in the body. 53 Onset of these symptoms varies from 2 weeks to 3 years: Committee on Genetics (1996), 476. 54 Wolf No2 (2005), 1. 55 Barry Wolf, “Biotinidase: Its Role in Biotinidase Deficiency and Biotin Metabolism,” (2005) 16 Journal of
Nutritional Biochemistry 441, 441 (Wolf No1) Rashes, alopecia, loss of muscle tone and seizures improve. 56 Wolf No2 (2005), 1-2. 57 Peter Weber, Sabine Scholl, and E Regula Baumgartner, “Outcome in Patients with Profound Biotinidase Deficiency: Relevance of Newborn Screening (2004) 46 Developmental Medicine & Child Neurology 481, 483 58 Labplus website http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006. 59 This leads to a toxic accumulation of these amino acids in the body: Karen Heldt, et al “Diagnosis of MSUD by Newborn Screening Allows Early Intervention Without Extraneous Detoxification” (2005) 84 Molecular
Genetics and Metabolism 313, 313. 60 Committee on Genetics (1996), 478. 61 D. Holmes Morton, et al “Diagnosis and Treatment of Maple Syrup Disease: A Study of 36 Patients” (2002) 109(6) Pediatrics 999, 1000. 62 Early treatment results in a better long term neurological outcome: C le Roux, “Neuropsychometric Outcome Predictors for Adults with Maple Syrup Urine Disease” (2006) 29 Journal of Inherited Metabolic Disease 201, 202.
7
MSUD patients must follow a severely restricted diet, similar to that used for PKU.63 Patients
cannot consume natural protein, such as meat, dairy products, and some fruit and vegetables.64
Even with NBS, some children suffer irreversible brain damage because of the early onset of
this disorder.65 However, effective NBS is still more desirable than clinical diagnosis of
MSUD, and is important for reducing mortality and long term damage.66
3.6 Congenital Adrenal Hyperplasia
Congenital Adrenal Hyperplasia (CAH) affects 1 in 20,000 newborns.67 CAH patients have
an enzyme deficiency which causes excess production of male hormones.68 Some female
children are born with ambiguous genitals69 and can therefore be diagnosed quickly using
clinical means.70 Other symptoms include salt wasting shortly after birth,71 accelerated growth
initially, but a stunted and short final stature, early puberty, virilisation, 72 and fertility
problems in females.73
CAH patients must take steroid hormone supplements for life, to suppress excess production
of male sex hormones.74 Early treatment usually prevents virilisation, early puberty, and
accelerated growth, and reduces fertility problems. 75 Nevertheless, CAH patients are
63 Morton (2002), 1000. It is hard to keep blood levels of BCAA stable, especially during periods of illness, stress or fasting, or exercise, which can lead to protein break down in the body and an increase in blood BCAA levels. They pose a risk of further brain damage, even in childhood or adulthood. 64 Patients must also take supplements to provide other necessary amino acids and vitamins: Paula Hallam, M Lilburn, and P J Lee, “A New Protein Substitute for Adolescents and Adults with Maple Syrup Urine Disease (MSUD)” (2005) 28 Journal of Inherited Metabolic Disease 665, 666, 671. 65 For this reason, fast turn-around of results is imperative: Committee on Genetics (1996), 479. 66 Morton (2002), 1004; E Simon, et al, “Maple syrup urine disease: Favourable effect of early diagnosis by newborn screening on the neonatal course of the disease” (2006) 29 Journal of Inherited Metabolic Disease 532, 534. 67 Labplus website http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006. 68 For example, testosterone: Heino F L Meyer-Bahlburg, et al, “Gender Development in Women with Congenital Adrenal Hyperplasia as a Function of Disorder Severity” (2006) August 11, electronic publication ahead of print Archives of Sexual Behaviour p(1). 69 U Kuhnle, and M Bullinger, “Outcome of Congenital Adrenal Hyperplasia” (1997) 12 Pediatric Surgery
International 511, 511. Ambiguous genitalia can be corrected by surgery. 70 Committee on Genetics (1996), 480. 71 This means that the kidney excretes large amounts of salt despite the body's need to retain it, which can lead to life threatening shock: Committee on Genetics (1996),480. 72 This term refers to the development of male sexual characteristics in females and the premature development of sexual characteristics in males. 73 Committee on Genetics (1996), 479-480. 74 Kuhnle (1997), 511. Patients who suffer from salt wasting symptoms must also take further supplements to control salt imbalance. This is a balancing act, as negative consequences result from both under and over treatment: Irini Manoli, et al, “Early Growth, Pubertal Development, Body Mass Index and Final Height of Patients with Congenital Adrenal Hyperplasia: Factors Influencing the Outcome” (2002) 57 Clinical
Endocrinology 669, 669. 75 Committee on Genetics (1996), 480.
8
generally shorter than average.76 NBS plays an important role in facilitating early treatment,
where patients do not exhibit ambiguous genitalia.
3.7 Cystic Fibrosis
Cystic Fibrosis (CF) affects 1 in 3000 newborns.77 It is caused by a deficiency in a protein
which controls salt movement in the body.78 CF patients excrete thick mucus, which causes
lung obstructions and a vulnerability to respiratory infections. Lung disease, malnutrition,
stunted growth, infertility in boys, and liver disease are also common.79 CF is hard to
diagnose clinically at birth because the symptoms appear progressively. 80 This delay is
associated with malnutrition and increased lung problems.81
There is no diet or medication to prevent these symptoms. Nevertheless, early diagnosis has
been associated with long term benefits. Early treatment with nutritional supplements reduces
malnutrition,82 resulting in improved long term growth and cognitive function. 83 Other studies
indicate that early treatment provides the potential for good lung function, although the long
term outcome is influenced by other factors.84 While there is no miracle treatment for CF,
NBS provides affected children with a better quality of life than clinical diagnosis.
4. Impact of New Technology
It is anticipated that a ‘tandem mass spectrometer’ will be used for NBS in New Zealand from
December 2006.85 The NBS programme will be expanded to screen for 29 disorders.86
76 Ga´bor Hargitai, et al, “Growth Patterns and Final Height in Congenital Adrenal Hyperplasia due to Classical 21-Hydroxylase Deficiency” (2001) 55 Hormone Research 161, 169. 77 Labplus website http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006. 78 Brice Marcet, and Jean-Marie Boeynaems, “Relationships Between Cystic Fibrosis Transmembrane Conductance Regulator, Extracellular Nucleotides and Cystic Fibrosis” (2006) July 7 electronic publication ahead of print Pharmacology and Therapeutics, p(1). 79 Committee on Genetics (1996), 483. The degree of severity depends on the particular genetic mutation. 70%
of CF patients have a ‘δ508’ mutation. The other 30% suffer from a wide range of different mutations which have varying clinical outcomes. 80 Philip M Farrell, et al, “Early Diagnosis of Cystic Fibrosis Through Neonatal Screening Prevents Severe Malnutrition and Improves Long-Term Growth” (2001) 107 Pediatrics 1, 2 (Farrell No1). Note that approx 10% of CF children are born with an intestine obstruction and are quickly diagnosed clinically. Up to half of CF patients diagnosed clinically are more than a year old and 25% are not diagnosed until they are more than 2 years old. Committee on Genetics (1996), 483. 81 Farrell No1 (2001), 2. 82 Malnutrition is caused by poor absorption of nutrients, particularly fat, protein and fat soluble vitamins and can be prevented by dietary supplements of vitamins, and pancreatic enzymes: Rebecca L Koscik, et al, “Preventing Early, Prolonged Vitamin E Deficiency: An Opportunity for Better Cognitive Outcomes via Early Diagnosis Through Neonatal Screening” (2005) 147(Supplement 3) The Journal of Pediatrics S51, S51. 83 Philip M Farrell, et al, “Evidence on Improved Outcomes with Early Diagnosis of Cystic Fibrosis Through Neonatal Screening: Enough is Enough!” (2005) 147(Supplement 3) The Journal of Pediatrics S30, S35 (Farrell No2). 84 Farrell No2 (2005), S35. 85 Correspondence with Dr Dianne Webster, Director of the National Testing Center in New Zealand, 5 October 2006. This centre is responsible for carrying out NBS tests in New Zealand.
9
Tandem mass spectrometry is a new testing technique, which is quick, cost-efficient, and
detects many disorders using a single test.87 This technology is in use in parts of Europe,
Australia, and the USA. For the purposes of this dissertation the legal issues remain the same.
The NBS programme will operate in the same manner, with the only change being the number
of disorders screened for.
5. False Positive and False Negative Results
False positive and false negative results are a risk in any testing procedure. A false positive
result indicates a child has a disorder, when in fact they do not. It is estimated that 1% of
screened newborns will return a false positive result.88 These results can be corrected quickly
using other diagnostic methods.
False negative results indicate that a child is healthy when they are actually affected by a
disorder. The impact of false negative results varies depending on the disorder and there can
be many reasons for a child being missed.89 Statistics on false negative results are therefore
harder to collate. However, the incidence of false negative results can be described as
negligible.90 Tandem mass spectrometry is proving to be highly accurate, with some studies
reporting no false negative results for a wide range of disorders.91
6. Conclusion
NBS tests are simple, non-invasive, and identify children affected by serious metabolic
disorders. Early diagnosis can prevent death, irreversible brain damage, and physical
disabilities. There are also benefits for the families of affected children and the State, which
will be addressed in chapters three and four. Given these benefits, should NBS be mandatory?
This question is considered in detail in the following sections of this dissertation.
86 Correspondence with Dr Dianne Webster, 5 October 2006. Note that this number can be interpreted differently depending on the way disorders are classified. Five disorders will be tested for using current technology. 87 For a simple explanation of how a tandem mass spectrometer works, see the Pediatrix Screening website, Pediatric Medical Group, Tandem Mass Spectrometry at http://www.pediatrix.com/body_screening.cfm?id=343 accessed 6 October 2006. For more detail see Rodney J Pollitt, et al, “Neonatal screening for inborn errors of metabolism: cost, yield and outcome” (1997) 1(7) Health Technology Assessment (No1), 16-19. 88 Pollitt No1 (1997), 140. 89 Pollitt No1 (1997), 16, 18. For example, laboratory error, contamination, or inadequate food intake before testing. 90 Kerruish, (2005), 394. 91 Pollitt No1 (1997), 19; Donald H Chace, et al “Use of Phenylalanine-to-Tyrosine Ratio Determined by Tandem Mass Spectrometry to Improve Newborn Screening for Phenylketonuria of Early Discharge Specimens Collected in the First 24 Hours”(1998) 42(12) Clinical Chemistry 2405.
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Chapter Two: The Court’s Power to Consent to Newborn Screening
1. Introduction
This chapter examines whether the New Zealand courts would use their powers to consent to a
NBS test, against parents’ wishes. The scenario to be considered is where both parents are
guardians, have been informed about the risks and benefits of NBS, and after considering this
information, have refused to consent to a NBS test for their child.92 The question is whether
the court would interfere in these circumstances to override the parents’ refusal. This chapter
also briefly addresses the personal liability of parents who refuse consent to NBS.
2. Jurisdiction of the Court
The High Court has an inherent jurisdiction to exercise parens patriae powers over
incompetent persons including children.93 However, this power is rarely used and has largely
been replaced by statutory powers granted to both the specialist Family Court and High Court,
under the Guardianship Act 1968,94 its successor The Care of Children Act 2004 (COCA), and
The Children, Young Persons, and Their Families Act 1989 (CYPFA).95
The COCA provides the court with a statutory jurisdiction to grant an order placing a child
under the guardianship of the court and ordering any person to be the court’s agent, generally
or for a particular purpose.96 As a guardian, the court can consent to medical procedures on
behalf of the child.97 When exercising this power, the welfare and best interests of the child
are the paramount consideration.98 In the scenario being considered, an application will most
likely be made by a health provider. They may apply only with leave from the court.99
92 It is accepted that it is possible for complicated fact scenarios to arise in this area of law. For example, parents can be separated, parents don’t always agree about providing medical treatment, not all parents are guardians of their children, and not all guardians will be parents of the child concerned. This dissertation will be limited to the basic scenario where both parents agree not to have their child screened. 93 Pallin v Department of Social Welfare[1983] NZLR 266, 272. Cooke J expressly recognised that the court still has such a power in relation to children. 94 Most New Zealand guardianship cases were decided under this legislation. The COCA replaced this Act on 1 July 2005. 95 For the purpose of this dissertation nothing turns on whether the court exercises its inherent or statutory jurisdiction. In Re Norma [1992] NZFLR 445, 450 Tompkins J stated that the court might use its parens partriae jurisdiction where consent is sought to a specific single treatment. He considered the statutory jurisdiction to be more appropriate where ongoing supervision of treatment is needed. 96 Section 33(1), COCA. 97 The court has used this jurisdiction (largely under the Guardianship Act 1968) several times. See for example Re J (An Infant): Director General of Social Welfare v B and B [1995] 3 NZLR 73 (HC), Re Norma, Re CL [1994] NZFLR 352, Re V [1993] NZFLR 369, Re P [1992] NZFLR 94, Director General of Social Welfare v Ulutau (1988) 5 NZFLR 631, Healthcare Otago Ltd v Williams-Holloway [1999] NZFLR 804. 98 Section 4, COCA. 99 Section 31(1), COCA states that an eligible person may apply. An eligible person is defined in section 31(2)(g), COCA to include any person with leave of the court.
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The CYPFA provides the court with a wide range of powers, including the power to remove
and appoint guardians, where a child is considered to be in need of care and protection.100
Where the parents have failed to provide a child with the necessities of life the court can also
impose criminal liability under the Crimes Act 1961 (NZCA).101
3. The Parental Right to Give Informed Consent on Behalf of Children
There is no legislation dealing specifically with procedural requirements or consent for NBS.
The ordinary rules regarding consent to medical treatment therefore apply.102 The Code of
Health and Disability Services Consumers’ Rights 1996 (Code of Rights) states that informed
consent must be obtained from a consumer before health services are provided.103 ‘Consumer’
is defined in the Code of Rights to include a person entitled to give consent on behalf of that
consumer.104 As a newborn is incompetent,105 consent must be obtained from a guardian, who
has the right to make decisions regarding medical treatment for that child.106 This right is also
recognised at common law.107 Although it was assumed that parents had such a right, it was
not clearly recognised by the English courts until the 1960s.108
3.1 Limitations on the Parental Right to Consent
Parents are permitted to make decisions on behalf of their children because they are in the best
position to assess the child’s unique needs and make decisions that benefit that child.109
However, parents’ right to consent or refuse consent to medical procedures is not absolute.110
In Gillick v West Norfolk and Wishbech Area Health Authority (Gillick),111 it was held that the
scope of parental rights is reflective of the duties parents owe towards children. 112
Guardianship rights exist for the benefit of the child rather than the parent.113 Therefore, the
100 ‘A child in need of care and protection’ is defined in Section 14(1), CYPF 1989. 101 Under section 152 of the Crimes Act 1961 it is an offence to fail to provide a child with necessaries when under a duty to do so. The maximum sentence is 7 years imprisonment. 102 Note: It is not doubted that informed consent is required before a NBS test can be carried out: Privacy Commissioner (2003), 8; Health and Disability Commissioner (HDC) Case Number 99HDC09011, 4 August 2000. 103 Right 7(1), Code of Rights. 104 Section 4, Code of Rights. 105 They are not competent in terms of section 36(1) and (2) of the COCA nor are they ‘Gillick competent.’ 106 Sections 16(2)(c) and 36(3)(a) of the COCA state that the rights of a guardian include the right to make medical decisions on behalf of a child. A parent will usually be a guardian of the child. 107 Re J (An Infant): B and B v Director General of Social Welfare [1996] 2 NZLR 134 (CA), 145, per Gault J. 108 P D G Skegg, Law, Ethics, and Medicine: Studies in Medical Law (Clarendon Press, Oxford, 1988), 58; Re L [1968] P. 119, 131-132, per Ormrod J; B. (B.R.) v B. (J.) [1968] P. 446, 477 per Diplock J. 109 Douglas Diekema, “Parental Refusals of Medical Treatment: The Harm Principle as Threshold for State Intervention” (2004) 25 Theoretical Medicine 243, 244. John Caldwell, “Parents, Courts, and the Sick Child” (2000) 3 Butterworths Family Law Journal 129, 130. 110 See for example, Re CL, Re Norma, Re V, and Re J (HC). 111 Gillick v West Norfolk and Wishbech Area Health Authority [1986] AC 112. 112 Gillick, 184-5, per Lord Scarman, and cited with approval in Re J (CA), 145, per Gault J. 113 Gillick, 170, per Lord Fraser. W J Brookbanks, “Religious Parents and Neglected Children” (2002) 4 Butterworths Family Law Journal 97. 99.
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primary function of the parental right to consent to medical treatment is to protect the welfare
of the child.114
3.2 Duties of Parents
In any guardianship proceedings, the court must decide what is in the best interests of the
child.115 Defining the duties of parents and how the ‘best interests’ test should be applied is
critical to determining whether the courts should override a parental refusal of NBS. The
fundamental concept behind the ‘best interest’ test is that no one should consent or refuse
consent to procedures, on behalf of another, where it would risk the infliction of some harm to
that person.116 In practice though, application of this test is not always straightforward.117
The parental duty to act in the best interests of a child cannot mean that parents should never
make decisions that place the child at some risk.118 Society grants parents a high degree of
freedom to determine the risks their child is exposed to.119 For example, parents take children
in cars and aeroplanes, cross busy roads with them, let them walk to school unaccompanied,
provide them with unhealthy food, and allow them to get their ears pierced.120 This list could
be extended by numerous other examples. In each situation there is some risk of harm, yet
neither the courts nor Parliament have prevented parents from taking such risks. This suggests
that parents can expose their children to some risks even where, as in the case of providing a
bad diet, there is no obvious benefit to the child.121
At the other extreme, there are situations where parents put their child at such risk that the
court will step in to assist that child. The CYPFA and NZCA indicate the minimum standard
of care that parents must provide to avoid court interference with their parental rights. That is,
parents must not inflict harm on their children. If a child is in need of care and protection, the
court may make a number of orders under CYPFA, including removing the child from the
parents care.122 For example, the court can intervene if a child is physically, emotionally, or
sexually abused, ill-treated, or neglected.123 Where a child suffers serious harm, or dies
114 Ruth R Faden, Neil A Holtzman, A Judith Chwalow, “Parental Rights, Child Welfare, and Public Health: The Case of PKU Screening” (1982) 72(12) American Journal of Public Health 1396 (No2), 1397. 115 As required by Section 4, COCA. 116 John Harris, “Mark Anthony or Macbeth: Some Problems Concerning the Dead and the Incompetent when it Comes to Consent” in Sheila A M McLean (ed), First Do No Harm, Law Ethics and Healthcare (Ashgate Publishing Group, 2006) 287, 298. 117 Skegg (1988), 59. 118 Diekema (2004), 244. If this were the case, very few parents would ever meet the required standard. 119 Skegg (1988), 66. 120 Harris (2006), 297-298 and Skegg (1988), 66. 121 Skegg (1988), 66. 122 If the court is satisfied that the child is in need of care and protection, a declaration can be made under section 67 CYPF. This declaration gives the court the power to make a number of orders that will provide that child with care and protection, as set out in section 83 CYPF. 123 Section 14(1)(a), CYPF 1989. See section 14(1), CYPF 1989 for more detail on the definition of a ‘child in need of care and protection.’
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because the parents fail to provide them with the necessities of life, the parents may also be
criminally liable under the NZCA.124 This liability will be given further consideration below.
The court can also intervene under the COCA in situations between these two extremes, when
parents do not act in a child’s best interests.125 Drawing a line between the risks parents can
and cannot expose their child to is difficult and much turns on the particular facts of each case.
This chapter examines which side of this line refusing NBS should sit. Failure to screen puts a
child at risk, albeit remote, of very serious physical and mental abnormalities. However, a
child’s best interests cannot be determined by a purely scientific or statistical analysis of
medical outcomes.126 Situations involving medical treatment of children also raise ethical and
social value questions to which medicine has no answer.127 Factors, such as the effect on the
family when parental decisions are overturned, are also relevant. 128 These factors are
considered as they apply to the NBS situation.
4. Use of the Guardianship Jurisdiction to Consent to NBS
The court has previously used its guardianship jurisdiction for a wide range of purposes,129 but
not as yet to consent to NBS. To predict the court’s approach to the scenario being considered,
this chapter examines a number of similar cases and how they might apply to this new fact
scenario.
The Irish Supreme Court is the only court to have considered consenting to NBS, in North
Western Health Board v. W. (H.) (NWHB).130 In Re C (A Child),131 the English courts granted
an order requiring a baby to be tested for HIV. There are also a number of cases dealing with
consent to medical treatment more generally. Finally, there is conflicting case authority, both
in the United Kingdom and New Zealand, regarding the use of the guardianship jurisdiction to
consent to taking blood samples from children for paternity testing.
4.1 Decisions Regarding the Testing of Newborns
(a) Newborn Screening in Ireland: North Western Health Board v W. (H.)
The Irish Supreme Court case, NWHB, is the only time a court has considered overriding a
parental refusal of NBS. The parents saw the test as invasive and harmful to their child,132 but
124 Section 152, NZCA. 125 The inherent, parens partriae jurisdiction could also be used. 126 Re Norma, 451, per Tompkins J. 127 Goldstein, Joseph, “Medical Care for the Child at Risk: On State Supervention of Parental Autonomy” (1977) 86 The Yale Law Journal 645, 644. 128 Re Norma, 451, per Tompkins J. 129 These have included giving consent to medical procedures, such as blood transfusions and chemotherapy, and giving consent for DNA samples to be taken. 130 North Western Health Board v. W. (H.) [2001] IESC 70 131 Re C (A Child) [2000] Fam 48, [2000] 2 WLR 270, [1999] 3 FCR 289 (HC); Re C (A Child) [1999] 2 FLR 1004, [2000] Fam Law 16 (CA). 132 This was because NBS involved puncturing the child’s blood vessels.
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did not put forward any religious or medical reasons for their refusal. The court unanimously
accepted that NBS was in the best interests of the child medically, but the majority refused to
override the parents’ decision.
The decision must be considered in light of unique provisions in the Constitution of Ireland
(‘the Constitution’),133 as the case was argued based on constitutional principles, rather than as
a guardianship case. The plaintiff claimed that the parents’ refusal was a failure to vindicate
the rights of the child as required by the Constitution.134 Determining the child’s best interests
required consideration of parental responsibility, the child’s personal rights, and the family’s
right to determine what is in the best interests of the child.135
The majority emphasised the family’s right to determine the upbringing of a child.136 The
family has a unique status in Ireland. The Constitution recognises the family as the “natural
primary and fundamental unit group of Society, and as a moral institution possessing
inalienable and imprescriptible rights, antecedent and superior to all positive law.”137 The
State can only interfere in exceptional circumstances, where “parents for physical or moral
reasons fail in their duty towards their children.”138 The Court held that intervention is only
appropriate where the “disastrous consequences of a particular parental decision are so
immediate and inevitable as to demand intervention and perhaps call into question either the
basic competence or devotion of the parents.”139 The majority of the Court thought that
refusing NBS did not reach this threshold because the risk of harm was remote and the child
was not in any immediate danger.140
This decision largely relied on particular terms of the Irish Constitution, and to that extent is
not directly applicable to New Zealand. While New Zealand has no equivalent provision
protecting the family’s rights, the approaches of both jurisdictions to medical treatment cases
are quite similar. The New Zealand courts are also reluctant to override parents’ decisions.141
They generally only intervene where treatment, such as a blood transfusion or chemotherapy,
is needed to prevent death or serious harm. There are no similar, reported cases decided by
133 The Constitution of Ireland has been in force since 29 December 1937. 134 As required by Article 40.3.1 of the Constitution. The Plaintiff also applied for a mandatory injunction ordering the parents to give consent for the test as well as interlocutory orders allowing the test to be carried out without the parents’ consent and preventing them from impeding the test being carried out: NWHB para [14], per Keane CJ. 135 NWHB para [182], per Denham J. 136 NWHB para [185], per Denham J. 137 Article 41.1 of the Constitution. 138 Article 42.5 of the Constitution 139 NWHB paras [208]-[209], per Murphy J. 140 See for example NWHB para [230], per Murray J and para [354], per Hardiman J. 141 The approach of the New Zealand courts to overriding parental refusals of medical treatment is discussed below, in section 4.2 of this chapter.
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the Irish courts. However, in JM v The Board of Management of Saint Vincent's Hospital142
the court overrode an incompetent adult’s decision to refuse a blood transfusion.143 The Irish
High Court recently ordered that a woman receive a blood transfusion against her wishes, after
haemorrhaging while given birth, because it would be in the best interests of her newborn
child.144 These decisions indicate that the Irish courts would approach the medical treatment
of children in a similar way to the New Zealand courts.
As in New Zealand, medical tests and treatment are generally not compulsory in Ireland. The
Court in NWHB was also concerned that granting the orders sought would essentially make
NBS compulsory. This would substantially change the State’s approach to consent for
medical treatment.145 The court considered this policy decision more appropriate for the
legislature.146
Chief Justice Keane dissented.147 He did not consider that granting the orders sought in
NWHB would necessarily mean that NBS would become compulsory. The parents in NWBH
put forward no reason, religious, scientific, medical, or otherwise, to support their decision to
refuse consent. The Chief Justice thought that sound arguments, based on religious grounds,
or proof that reliable results could be determined using non-invasive means, would need to be
considered by a court and could produce a different result.148
The majority has been criticised for placing too much emphasis on parents’ rights rather than
their responsibilities, and for creating a low threshold for satisfaction of parental duties. 149
One commentator has argued that the majority focussed too greatly on maintaining parental
rights as against the state, and too little on the child’s rights as against their parents.150
While the decision in NWHB was based on Irish constitutional provisions, as the only case to
consider a refusal of NBS, the Court’s reasoning is likely to be considered carefully in any
New Zealand case. NBS is voluntary in New Zealand. If court consent to NBS in a single
142 JM v The Board of Management of Saint Vincent's Hospital [2003] 1 IR 321. 143 The woman had recently married a man of the Jehovah’s Witness faith and adopted this religion. She had discussed consenting to blood transfusions when lucid but refused consent in circumstances which indicated she was not competent. 144 Eithne Donnellan, “Woman in court transfusion case recovering in hospital” The Irish Times, 22 September 2006, online at http://www.ireland.com/newspaper/front/2006/0922/115859088 1290.html accessed 7 October 2006. This case has not yet been reported. The only reports of this case have been in the Irish media, so a clear statement of the Court’s opinion is not available. 145 NWHB para [177], per Denham J. 146 NWHB para [316], per Hardiman J. 147 Keane CJ would have ordered the test, as he believed the plaintiffs had established that the constitutional rights of the child could only be maintained if the test was ordered: NWHB para [125]. 148 NWHB para [123]-[124], per Keane CJ. 149 G Laurie, “Better to Hesitate at the Threshold of Compulsion: PKU Testing and the Concept of Family Autonomy in Eire” (2002) 28 Journal of Medical Ethics 136 (No1), 137. 150 Laurie (2002), 137.
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case would result in NBS becoming compulsory, this may persuade the Court to refuse to
grant any orders sought.
(b) HIV Diagnostic Testing: Re C (HIV Test)151
This case concerned a five month old baby born to an HIV positive mother. The mother had
refused conventional treatment herself, treating the problem by living a healthy lifestyle.152
The family’s general practitioner urged the parents to have the child tested for HIV.153 When
the parents refused this recommendation, the local health authority, applied to the court for an
order that a blood sample be taken and tested to determine the baby’s HIV status. The High
Court decision granting this order was later upheld by the Court of Appeal.
The important issue for the court was the need to know the child’s state of health. Lady
Butler-Sloss stated:154
In my view, the child is clearly at risk if there is ignorance of the child’s medical condition. The degree of intrusion into the child of a medical test is slight. The degree of intrusion into the family of taking the child to the hospital for a medical test would for most people be comparatively slight…Can it be in the child’s best interests for the parents to remain ignorant of their own child’s state of health? You only have to ask that question for most people to say no.
This reasoning is applicable to NBS. It is not in a child’s best interests for parents or medical
professionals to be ignorant of their condition. Knowledge that a child has a NBS disorder,
combined with appropriate treatment, dramatically improves the short and long term outcome
for that child. The potential for long term benefit is arguably greater from early diagnosis of
NBS disorders than with HIV.155 The heel prick procedure is less invasive than that used to
obtain a blood sample for HIV testing and in most cases the parents will not need to bring the
child to hospital for testing.156 This case could therefore support an order giving consent for
NBS.
However, there are some important factual differences that distinguish this case. In Re C, the
child had a 20-25% of having HIV.157 Without appropriate treatment she risked suffering
151 Re C (A Child) [1999] 2 FLR 1004 (CA). 152 There was evidence that the mother did not actually believe the HIV virus existed and therefore saw no point in conventional treatment. 153 The baby may have contracted the virus during pregnancy, birth, or breast feeding. 154 Re C (CA), per Butler-Sloss LJ, page numbers not available for this case. It can be accessed online at http://www.bailii.org/cgi-bin/markup.cgi?doc=/ew/cases/EWCA/Civ/1999/3007.html&query=+c+HIV&method =all. 155 Children with HIV will eventually progress to AIDS and die, while many of those with NBS disorders can go on to lead relatively normal lives. 156 The test is usually done before the child leaves the hospital. In the case of home births the lead maternity carer is responsible for collecting the sample and will usually come to the family home. 157 Re C (A Child) [2000] Fam 48 (HC), 54, per Wilson J.
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from AIDS related illnesses158 and had a 4% chance of death before her first birthday.159
There was a real risk that the child had contracted HIV, which cannot be said of most newborn
children with regard to the NBS disorders.160
A further distinction of this case was made in NWHB.161 The precedential value of Re C is
limited. It is not an authority requiring all babies to be tested for HIV. Conversely, if a New
Zealand Court held that a newborn child, with no family history of a NBS disorder, must be
tested, then NBS would effectively become compulsory. The courts would be reluctant to
apply this case to NBS because of the potentially far-reaching consequences of such a decision.
However, Re C may well support the court consenting to NBS if a child has an increased risk
of having a disorder. For example, if a child has a sibling with PKU, there is a 25% chance
that child will also have the disorder.162 It would be difficult to distinguish Re C in such a
situation and it is likely that this increased risk would persuade the court to consent to NBS.
(c) New Zealand: Health and Disability Commissioner (HDC) Decisions
The New Zealand HDC has commented on consent to NBS in two investigations. The
commissioner found that it is a breach of the Code of Rights to conduct a NBS test without
obtaining consent from the child’s parents.163 It is also a breach of the Code of Rights to
threaten to contact the Children Young Persons and Their Family’s Service when parents
refuse consent.164 These decisions confirm that NBS is voluntary in New Zealand. The Code
of Rights would be relevant to a court considering an application under the COCA for the
purposes of consenting to NBS.
4.2 Cases Regarding the Medical Treatment of Children Generally
None of the above decisions are binding in New Zealand. It is therefore important to examine
the approach of the New Zealand courts to the medical treatment of children. The New
Zealand courts have placed children under the guardianship of the court for the purpose of
consenting to a number of treatments, including blood transfusions,165 chemotherapy,166 and
158 Such as PCP (Pneumocystis Carinii Pneumonia): Re C (HC), 56, per Wilson J. 159 Re C (HC), 56, per Wilson J. 160 The risk of having a NBS disorder is much less than 1%. 161 NWHB para [168], per Denham J. 162 If an older sibling has PKU this means that the parents of the child are both carriers for the disorder. PKU is inherited in an autosomal recessive fashion. Where the parents are both carriers, there is a 25% chance that the child will have the disorder. See appendix one for further explanation. 163 Case Number 99HDC09011, 4 August 2000. Auckland Healthcare was found to have breached rights 7(1) and 7(9). 164 Case Number 99HDC09973, 19 December 2001, Ron Patterson. The conduct of a paediatrician was found to have breached right 2 and 5. 165 Re V, Re J, Re CL, Re P, Director General of Social Welfare v Ulutau. Refusal in these cases is usually based on religious grounds.
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removing tumours.167 In each case, the court’s paramount concern was the welfare and best
interests of the child.168 This section will address the factors that New Zealand courts have
considered important and how they are relevant to NBS.
(a) Objective Medical Benefits
The medical benefits of any procedure, and the health risks associated with both treatment and
failure to treat, are obviously relevant to the welfare of a child, and therefore important to the
court.169 However, there must be a serious risk to the health of the child before the court will
intervene. In Re J,170 the court held that a guardianship order ‘should only be made where the
child’s life or well being is in serious jeopardy and there is no other reasonable medical or
therapeutic treatment available.’171 For example, in Re J the child would have died without a
blood transfusion, therefore the child was at serious risk of harm.172 This appears similar to
the approach of the Irish Supreme Court in NWHB.173 The court has also used the child’s right
to life, as protected by section 8 of the New Zealand Bill of Rights Act 1990 (NZBORA), as
support for exercising its guardianship jurisdiction.174
The risks associated with NBS are slight and the benefits are potentially huge.175 However, an
argument that failing to screen places a child at an appreciable risk of death or serious
disability, or that the child is being denied his or her right to life, would require a strained
interpretation of previous medical treatment cases.176 While affected children risk death or
serious disability without treatment, the disorders tested are all very rare. This low risk of
harm distinguishes refusing consent to NBS from cases where the court has exercised its
166 Auckland Healthcare Services Ltd v T [1996] NZFLR 670, Re Norma, Healthcare Otago Ltd v Williams-
Holloway. 167 Director General of Social Welfare v B [1994] NZFLR 516. 168 Section 4(1), COCA. See for example Re Norma, 451, per Tompkins J and Re CL, 357, per Robertson J. This has been a statutory consideration since the implementation of the Guardianship Act 1968 but is also a valid principle under the common law. 169 Re Norma, 451, per Tompkins J. 170 Re J (An Infant): Director General of Social Welfare v B and B, [1995] 3 NZLR 73 (HC); Re J (An Infant): B
and B v Director General of Social Welfare, [1996] 2 NZLR 134 (CA) 171 Re J (HC), 88 and cited with approval in Re J (CA), 139. Other cases support this approach. In Re Norma, 451 the Court held it had a duty to intervene where a child required ‘essential medical treatment’. In Re P, 96 it was held there must be a ‘real and substantial risk of death.’ 172 Another example is Re Norma, where medical evidence stated that without appropriate treatment for bone cancer Norma would die. See also Healthcare Otago Ltd v Williams-Holloway (the child required chemotherapy to have any chance of survival) and Re CL (the child may have required a life-saving blood transfusion during an important operation). 173 See NWHB, para [208]-[209], per Murphy J, where he defines the exceptional circumstances required before the court will step in. 174 See for Example Re J (HC), 80-82, per Ellis J and Re J (CA), 143, 146, per Gault J. 175 See chapter one and appendix one of this dissertation for more details. It was unanimously accepted in NWHB
that the benefits outweighed any risks associated with NBS. 176 Ainsley Newson, “Should Parental Refusals of Newborn Screening Be Respected?” (2006) 15 Cambridge
Quarterly of Healthcare Ethics 135, 138.
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guardianship jurisdiction in the past. This would justify a court refusing to place a child under
its guardianship.
NBS is a test rather than a treatment for a diagnosed disorder. However, the court is unlikely
to refuse to excuse its guardianship jurisdiction on this ground alone. In both Re Norma and
Re C, the Court used its jurisdiction to order tests for cancer and HIV respectively.
(b) Effectiveness of the Proposed Procedures
In Re J, Ellis J held that parents’ rights should be upheld where there is no other treatment
available, or there are serious doubts about the efficacy and suitability of the proposed
treatment.177 However, in all major New Zealand cases, the courts have refused to uphold the
parents’ decision to use ‘alternative treatments.’178 A court is more likely to override parents’
decisions if they are based on religious or other unconventional grounds.179 For example, in
Re Norma, the Court preferred conventional cancer treatment over traditional Samoan healing.
In Re T,180 a refusal to consent to a liver transplant, by parents who were also health
professionals, was based on the medical prognosis for the child. There was no guarantee the
surgery would be successful. The surgery was still experimental, and there would still be
serious medical concerns for the child following surgery. Importantly, for these reasons, at
least one practitioner was not prepared to conduct the surgery without the mother’s consent.
The Court thought this distinguished the case from those where the parents’ decision was
based purely on religious dogma, and refused to intervene.181
The use of blood spot analysis for NBS is widely recognised as the most effective way to
detect a range of metabolic disorders and allow for early treatment.182 While there is a
possibility of incorrect results, the NBS test is very accurate.183 The alternative method,
clinical diagnosis, can take months, or even years and is often not possible until serious,
irreversible symptoms are present.184
177 Re J (HC), 82, observing with approval the Supreme Court of Canada’s approach in B(R) v Children’s Aid
Society of Metropolitan Toronto [1995] 1 SCR 315. 178 Caldwell (2000), 134. In this context ‘alternative treatments’ refers to treatment other than that adopted by conventional, Western medical practice. 179 See Re T (A minor) (Wardship: medical treatment) [1997] 1 WLR 242, 254, per Waite J. 180 Re T (A minor) (Wardship: medical treatment) [1997] 1 WLR 242. 181 Re T, 254, per Waite J. Note this decision on appeal overturned the ruling of the lower court who would have ordered the treatment. This indicates that there is no clear ‘right’ or ‘reasonable’ answer in these complex cases. 182 Kerruish (2001), 393. 183 See generally Chace (1998). 184 See chapter one, and appendix one for details about these disorders.
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It is unlikely a refusal of NBS could be based on medical grounds, as in Re T.185 It is therefore
arguable that Re T can be distinguished, and the parents’ decision overruled. However, while
clinical diagnosis is not ideal, the risk that the child will have to rely on this less suitable
diagnostic technique is very remote. Despite the fact any refusal cannot be medically
supported, NBS is still fundamentally different to cases such as Re Norma. Without an
immediate risk to the child, it is unlikely that the poorer results obtained using clinical
diagnosis will persuade the court to exercise its jurisdiction.
(c) Effect on the Family
The welfare of the family is important because a child’s welfare is at least partly determined
by the family and their place in it.186 Where a decision is likely to cause serious stress within a
family, this is a factor to be considered.187 Nevertheless, if the child’s life is in danger, the
court often adopts the approach suggested by conventional medicine.188
NBS creates minimal disruption to the family, especially when compared with cases such as
Healthcare Otago Ltd v Williams-Holloway,189 where the court ordered that the child receive
chemotherapy. Chemotherapy requires serious commitment from parents, but the court still
held that the best interests of the child lay in allowing treatment. By contrast, in Re T, where
the court declined to intervene, the effect on the family was an important reason for the
decision. The cooperation and dedication of the family in post-operative care was essential to
the success of a liver transplant, and therefore an important consideration.
A NBS test is generally conducted when the child is still in hospital, and there is no need for
subsequent care unless a positive result is returned. NBS therefore requires little commitment
from parents. This might suggest that the courts should use their powers to consent to NBS.
However, in previous cases, the court intervened in spite of the effect on the family because
the child was in a perilous position. In Re CL, Robertson J held:190
A court will always endeavour to intrude to the least extent possible on the family’s circle, but the welfare of the child is the paramount consideration and…there will be times when there must be intervention.
Therefore, the court protects the family, unless there are serious reasons not to. As discussed
earlier, it is unlikely that the remote risks associated with refusing NBS are sufficient to justify
185 The risk of harm from the test is negligible. It is also unlikely that a medical practitioner would lodge an application if there were medical reasons for not having the test done. 186 Re Norma, 451, per Tompkins J. 187 Re Norma, 451, per Tompkins J. 188 Blood transfusions are almost invariably ordered despite the stress this causes parents of the Jehovah’s witness faith, as are treatments for cancer. 189 Healthcare Otago Ltd v Williams-Holloway [1999] NZFLR 804 190 Re CL, 357.
21
intervention. The small impact on the family cannot be considered in isolation, and is unlikely
to be a determining factor in any NBS case.
(d) Conclusion
NBS is non-invasive, involves little impact on the family unit, and the alternative method of
clinical diagnosis is far less successful in preventing death and irreversible harm. These
features indicate the court should exercise its jurisdiction to give consent to NBS. However,
in all major New Zealand cases, the courts have clearly stated that intruding on the family is
only appropriate where there is a real risk of serious harm. The risk that a child will suffer any
harm at all, as a result of the parents’ refusal to consent to NBS, is very low for each child.
This makes NBS fundamentally different to previous medical treatment cases. Therefore, it is
likely that the court would refuse to exercise its guardianship jurisdiction to consent to NBS.
4.3 DNA Testing Cases
There is conflicting case authority regarding the use of the court’s guardianship powers to
consent to blood testing of children for the purpose of DNA paternity testing. In the recent
case of T v S,191 the Court of Appeal approved a High Court decision192 placing a child under
the guardianship of the court and consenting to the taking of a cheek sample for DNA analysis.
The court analysed conflicting cases in both New Zealand and England.
In Asomua v Thompson193 it was held (without reference to earlier authorities) that the court
did have jurisdiction to appoint a guardian for the purpose of consenting to blood testing. In
England, in Re R (A minor),194 the Court also used its guardianship jurisdiction for the same
purpose. By contrast, in the earlier case of Cairns v James195 Temm J refused to exercise the
court’s guardianship jurisdiction to consent to a blood test in the course of paternity
proceedings. He believed it would be inappropriate “to use this power to oust the mother's
right to decide for herself whether her child gives a blood sample or not.”196 In the English
case of Re O (A Minor),197 Wall J refused to exercise the jurisdiction on the same grounds.
The Court of Appeal, in T v S, 198 distinguished Re O because the relevant legislation
specifically required the consent of a person who had the care and control of the child before a
blood sample could be taken.199 The New Zealand paternity testing provisions only require
191 T v S [2005] NZFLR 466 (CA). 192 S v T [2003] NZFLR 223 (HC). 193 Asomua v Thompson, unreported, FC, Blenheim, FP006/220/97, 10 December 1998 Grace J. 194 Re R (A Minor) (Blood Tests: Constraint) [1998] 2 WLR 796. 195 Cairns v James [1992] NZFLR 353. 196 Cairns v James, 357. 197 Re O (A Minor) (Blood Tests: Constraint) [2000] 2WLR 1284. 198 T v S (CA), 479. 199 Section 21(3) Family Law Reform Act 1969. This legislation has since been amended to permit the taking of a sample where the court considers it to be in the best interests of the child.
22
consent from a person that is competent to do so.200 In Cairns, the Court was not prepared to
grant the orders sought until the plaintiff established a prima facie case that he was the
father.201 The Court of Appeal criticised this approach because it could prevent the court from
making decisions in the best interests of the child.202 The Court stated “that in appropriate
cases, where consent on behalf of a child to genetic testing is in the best interests of that child,
the Courts will ensure that a person prepared to give that consent is authorised to do so.”203
The Court held that it was in the best interests of the child to determine paternity conclusively,
as there was potential for serious psychological harm if the child uncovered an error in their
teenage years. In distinguishing Cairns, the Court in T v S thought it was important that there
was a real likelihood the plaintiff was the child’s father, while in Cairns the judge thought
there was no such likelihood.204
NBS provides certainty for the child in a similar way to paternity testing. However, because
the possibility of a child having a disorder is very small it is arguable that NBS is more like
Cairns. However, if a child had a family history of a disorder, and therefore a real likelihood
of having a disorder, T v S could support a decision to consent to NBS.
It was also relevant in T v S that the mother had given no substantive reason for refusing the
test, other than it was her preference the test did not take place. This is sometimes a feature of
newborn screening refusals. 205 Where parents cannot produce a specific reason for not
consenting to the test, this may weigh against respecting their views. On the other hand, where
parents have a religious or medical reason for refusing consent, the court may consider this to
be relevant.206
The Court in T v S attempted to resolve the different approaches taken in Asumoa and Cairns,
but only went as far as deciding that the court could use its jurisdiction to take a cheek swab.
The court considered this to be ‘less interventionist than a blood sample’ and provided another
ground on which to distinguish Cairns.207 It therefore does not entirely clarify the position
with regard to taking a blood sample, which NBS requires.
200 Section 57, Family Proceedings Act 1980. 201 Cairns v James, 357. 202 T v S (CA), p479. 203 T v S (CA), p480. 204 S v T (HC), 228 and cited with approval in T v S (CA), 475. 205 See HDC case number 99HDC09973, 19 December 2001 where the parents had given their doctor no specific reason for refusing consent. 206 Such an approach was suggested by Keane J in NWHB, para [123]-[124]. 207 S v T (HC), 228 and noted with approval in T v S (CA), 476.
23
(a) Conclusion
T v S was decided in the context of the Family Proceedings Act 1980, which contains specific
provisions for paternity testing. Despite this explicit regulation, the Court used its
guardianship jurisdiction to circumvent these provisions because it was in the best interests of
the child. The Court’s approach in T v S suggests, that unless a child has a special risk of
having a disorder, it is unlikely the court will use its powers to consent to NBS.
4.4 Conclusion: Exercise of the Court’s Guardianship Jurisdiction
The court’s approach to parents refusing consent to medical procedures is to interfere only
where a child is at serious risk of harm. NBS offers certainty, is clearly the most effective
method of preventing life-threatening and irreversible damage caused by NBS disorders, and
requires only a small intrusion on the rights of parents. Despite this, it is unlikely that the
court will use its guardianship jurisdiction to override a refusal of NBS.
The fundamental difference between refusing NBS and other cases where the court has
intervened is that the risks associated with a failure to screen are very remote, and there is no
immediate threat to the child’s health. The court is also likely to be concerned that exercising
its powers will lead to NBS becoming compulsory. Such a major policy change is more
appropriate for Parliament. If a child had a higher risk of having a disorder or was showing
symptoms of a disorder, the court may well find that the child is in serious and immediate
danger and override parental consent.
5. Personal Liability of Parents
There is a remote risk that an untested child will have a disorder and suffer harm because they
are not tested. The rest of this chapter examines whether parents who refuse consent risk
criminal or civil liability if a child suffers harm as a result.
5.1 Criminal Liability
Section 152 of NZCA states that where parents and guardians, under a duty to provide a child
with ‘necessaries,’ omit to do so without lawful excuse, they will be criminally liable if the
child dies, his or her life is endangered, or health permanently injured.208 Where the child dies
and the parents’ omission caused that death, this may also amount to culpable homicide under
section 160(1)(b) of the NZCA,209 making them guilty of manslaughter.210
208 The maximum penalty is seven years imprisonment (Section 152(2), NZCA). For a more thorough discussion of the application of this and similar provisions see Manning, Joanna, “Parental Refusal of Life-prolonging Medical Treatment for Children: A Report from New Zealand” (2001) 8 Journal of Law and Medicine 263, 280-284. 209 Section 160(1)(b), NZCA states that homicide is culpable, if it involves the killing of any person by an omission to perform or observe any legal duty, without lawful excuse. 210 Unless their actions come within sections 167 and 168 of the Crimes Act 1961, in which case they will be liable for murder.
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(a) Is NBS a ‘necessary’?
The term ‘necessaries’ includes medical aid, care, and attention.211 In R v Moorhead,212
failure to obtain blood tests when clearly necessary was one of the parents’ many failures to
provide necessaries.213 Therefore, the fact that NBS is a test and not a treatment, is unlikely to
be a bar to prosecution.
It is useful to compare NBS with other cases where prosecution was successful. In R v
Laufau,214 the parents were found guilty under section 152 of the NZCA for failing to consent
to cancer treatment after their 13 year old child refused further treatment. Without
chemotherapy the child would die, making the treatment ‘necessary’. In the Moorhead case,
the parents were found guilty of manslaughter for failing to treat their child for severe vitamin
B12 deficiency.215 The Moorhead case and refusal of NBS are similar, as a simple test and
injection, followed by dietary supplements would have prevented Caleb’s death. However,
Caleb was terribly ill for two months before his death, and the parents were told by several
doctors that he would die without treatment.216 The risk of death was clear and imminent, and
the treatment was necessary to avoid this fate.
These two examples indicate the kind of treatment regarded as ‘necessary’ in previous cases.
In both cases the court would have used its guardianship jurisdiction to ensure the child got
that treatment.217 As discussed above it is unlikely the court would do so if a parent refused
NBS. Refusal of NBS is different because it requires the testing of an asymptomatic child for
rare disorders. It is arguable that a NBS test is not ‘necessary’, as for most children it is not
needed to prevent harm. If parents were criminally liable for refusing to consent to NBS they
would also be liable in numerous other cases. For example, if a child died of meningitis and
the parents had failed to have the child vaccinated, they could be criminally liable. If
Parliament intended parents’ duties to extend this far, routine procedures like NBS should be
made compulsory by legislation.
211 Auckland Area Health Board v Attorney General [1993] 1 NZLR 235, 249. 212 R v Moorhead, unreported, HC Auckland, T011974, 13 June 2002, Harrison J. 213 See for example R v Moorhead, 5-6 and 9. 214 R v Laufau, unreported, HC Auckland, T000759, 2 October 2000 Potter J 215 The child’s mother was a vegan and herself B12 deficient. As a result the child was not getting enough vitamin B12. He essentially starved to death. 216 The child was pale, unresponsive, vomiting, suffering from a rash that became so bad it was often bleeding, his brain was wasting away, and he was suffering from malnutrition (when he died, aged 7 months, he weighed only 1.5kgs more than when he was born). See R v Moorhead, 5 and 12. 217 See R v Moorhead, 16 where the judge indicated that the court would protect Mrs Moorhead’s as yet unborn child from a similar fate. See also Re Norma, and Health Care Otago Ltd v Williams-Holloway for examples of cases where the court has overridden parents’ decisions to refuse chemotherapy.
25
If a child had a higher risk of having a NBS disorder,218 or became symptomatic, and the
parents still failed to consent to a test, the court may regard this refusal as a failure to provide
necessaries. There would be a clear indication that without the test the child could die or be
seriously harmed, making the situation more like Moorhead and Laufau.
(b) A Lawful Excuse
The court has been clear that a conscientious objection to medical treatment, or an honest
belief in alternative treatments based on religious grounds, does not provide a lawful excuse to
failing to provide a child with necessaries.219 Where parents intentionally or negligently fail to
act as a ‘reasonable parent’, this is enough for a conviction.220 Currently, 99% of parents,
whose children have almost no risk of having the disorders, consent to the test. It would
therefore be open to the court to find that a reasonable parent, knowing that their child is at
real risk of having a disorder, would have their child tested.
5.2 Civil Liability of Parents
It is also conceivable that a child might sue his or her parents in negligence for failing to
consent to NBS if that child suffers harm as a result of delayed diagnosis.221 To be successful,
the harm suffered by the child must fall outside the scope of the Injury, Rehabilitation, and
Compensation Act 2001 (IRCA). This Act imposes a bar on common law claims when the
plaintiff is entitled to compensation under the ACC scheme.222 To be covered by the ACC
scheme, the child must suffer ‘personal injury’223 of a kind described in section 20(1) of IRCA.
The relevant kind of personal injury is ‘treatment injury.’224 A ‘treatment injury’ is an injury
suffered when seeking or receiving medical treatment from a registered health professional.
Treatment includes the diagnosis of a person’s medical condition.225 The injury must be
caused by treatment and not be a necessary part, or ordinary consequence, of the treatment.226
Treatment injury does not include personal injury that is wholly or substantially caused by a
person's underlying health condition, or that is a result of a person unreasonably withholding
their consent to undergo treatment.227
It is arguable that any harm suffered is caused by the child’s underlying disorder and the
parents’ refusal to screen. The HDC found that a doctor breached the Code of Rights by
218 For example, if the child had a sibling with a disorder, or the parents were known carriers. 219 Manning (2001), 281. 220 Manning (2001), 281 See this article for a discussion on the reasonable parent standard and how it is assessed. 221 It is most likely that another person will sue on the child’s behalf as many children who are not diagnosed with the relevant disorders have serious mental disabilities. 222 Section 317(1)(a), IRCA. 223 As defined in section 26(1), IRCA. 224 Section 20(1)(b), IRCA. 225 Section 33(1), IRCA. 226 Section 32(1), IRCA. 227 Section 32(2), IRCA.
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pressuring parents, following a refusal of NBS.228 Therefore it is unlikely that a failure to
screen, following parental refusal, is a treatment injury. This means that harm suffered as a
result of parents’ refusing consent to NBS would not be covered by the ACC scheme.
If this is the case, then the child can pursue a claim in negligence. It could not be reasonably
doubted that parents owe their children a duty of care. As indicated in this chapter, the
conduct required by parents to discharge this duty is not always clear. Detailed analysis of the
parents’ duty of care for the purpose of the tort of negligence is outside the scope of this
dissertation, but the issue remains one to be considered should such a case arise.
228 HDC Case Number 99HDC09973, 19 December 2001, Ron Patterson.
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Chapter Three: Mandatory Newborn Screening Statutory Regime
1. Introduction
Chapter two concluded that the NZ courts are unlikely to use their guardianship jurisdiction to
consent to NBS, unless the child has an increased risk of having a disorder. The Irish
Supreme Court observed that removing parents’ rights to refuse consent to NBS was a policy
decision for Parliament. Chapters three and four of this dissertation consider whether
Parliament should make NBS mandatory by legislation.
This chapter outlines the forms a mandatory NBS programme could take and the aims of
introducing such a scheme. It then considers whether mandatory screening would be effective
in New Zealand. Chapter four considers whether an effective mandatory NBS programme is a
justified limitation on the rights of parents to determine the upbringing of their children.
2. The Importance of Addressing this Issue Now, Not Later
There is a remote risk that an unscreened child will have a disorder and suffer harm because of
late diagnosis. Society is rarely tolerant of parents making decisions that place a child at risk
of death or serious harm.229 If a child suffers because their parents refused consent to a non-
invasive procedure such as NBS,230 it is conceivable that the ensuing media coverage will lead
to calls for mandatory NBS to prevent this occurring again.
A similar phenomenon can be seen in relation to child abuse. When a child is killed or
seriously hurt as a result of child abuse, there are frequently calls for mandatory reporting of
suspected abuse.231 This fails to appreciate that children may stop reporting abuse if they are
concerned that their confidant is under a duty to contact police. However, while the media are
describing the horrific injuries suffered by the child, it is hard to present an argument against
mandatory reporting. This example highlights the importance of considering major policy
changes when the issue is out of media spotlight. This is the best way to ensure all sides of the
problem are carefully addressed.
It is therefore important to consider whether mandatory NBS is appropriate in New Zealand,
without the emotion that may be associated with a highly publicised case. If the issues are
229 Caldwell (2000), 129. It is accepted this is not always the case. For example in the well publicised case involving Liam Williams-Holloway many people did not support the Court’s decision requiring Liam to receive chemotherapy, when the parents had opted for alternative treatment. However, in subsequent cases the view of the public has been different. For example general public opinion was less supportive of the parents in the Laufau and Moorhead cases. 230 This is particularly evident when NBS is compared with treatments such as chemotherapy and blood transfusions. 231 Laurie O'Reilly, “Look back - step forward: Everyone an Advocate for Children” (1998) 2 Butterworths
Family Law Journal 213, 220.
28
considered before a child is harmed by a failure to screen, then a well considered response to
claims for mandatory NBS can be made.
Calls for mandatory screening could also be fuelled by health providers. Paediatricians, in
New Zealand and internationally, strongly support NBS.232 For example, in Maryland, 78% of
paediatricians favoured mandatory NBS, although most thought that parents should still be
informed about the procedure.233 Paediatricians witness the results of NBS and have a better
appreciation than most of the benefits it provides. However, because of this intimate
involvement, they may fail to appreciate any negative consequences of mandatory NBS.
Therefore, this dissertation considers the possible formats for NBS, and provides an objective
assessment of the reasons for and against mandatory NBS.
3. Defining a Mandatory Screening Programme
In deciding whether a mandatory NBS programme is appropriate, it is important to outline the
form it would take. This chapter examines the ‘mandatory screening’ programmes in the USA
and why they would provide little change if introduced in New Zealand. Secondly, this
chapter outlines a unique scheme, which places duties on both parents and health providers
and provides criminal sanctions for non-compliance.
3.1 Mandatory Screening in the United States of America
NBS is run at a state level in the USA, and the individual states have all adopted different
policies. NBS is considered by most states to be mandated by law, although in practice none
of the schemes are truly mandatory. Most states permit exceptions and provide no
enforcement measures.234 In outlining the possibilities for New Zealand, it is useful to look at
a variety of states to provide examples.
Rather than placing a duty on parents, most states impose a duty on health providers to ensure
that all children receive a NBS test. For example, the Iowa Code states:235
An attending health care provider shall ensure that every newborn under the provider's care is screened for congenital and inherited disorders in accordance with rules adopted by the department.
In other states, such as Georgia, health providers have a duty to ensure the test is done only
when a child is born in a hospital. In the case of a home birth, health providers must inform
parents, in writing, that the test must be completed and where the test can be done.236
232 This was noted in HDC case number 99HDC09973, 19 December 2001, 7. 233 Ruth Faden, et al “A Survey to Evaluate Parental Consent as Public Policy for Neonatal Screening” (1982) 72(12) American Journal of Public Health 1347 (No1), 1349. 234 Only the states of Wyoming and Maryland require informed consent before the test is carried out. 235 Iowa Code §136A.5(2) (2005). 236 Ga.Comp.R. & Regs.r. 290-5-24.02(4) (2006). The duty is then on the parents to have the child tested.
29
Although NBS is mandatory, there is little in the way of real enforcement. There appear to be
no direct consequences, set out in legislation, if health providers do not fulfil their duty.
Health providers and parents are potentially liable in tort if a child is not tested, but only if the
child suffers harm as a result.237 Parents are not under any statutory duty to have a child tested.
Imposing liability would therefore be difficult, and require a close analysis of the extent of
parental duties for the purposes of negligence.238
While NBS is thought to be mandatory, most states allow exceptions. States in the USA
generally operate on an opt-out basis.239 All children must be tested, unless a parent provides
a written refusal.240 The exceptions allowed in each state vary. Seventeen states allow parents
to refuse on any ground, for example, Iowa241 and Florida.242 Thirty three states allow parents
to refuse NBS on religious grounds only, but the requirements vary between states. 243 In
some states the parents must simply state in writing that they are objecting on religious
grounds.244 Others require parents to be more specific about their reasons for refusal. For
example, Kentucky legislation states:245
Nothing in this section shall be construed to require the testing of any child whose parents are members of a nationally recognized and established church or religious denomination, the teachings of which are opposed to medical tests, and who object in writing to the testing of his or her child on that ground.
South Dakota is the only state where NBS is fully compulsory, and allows no exceptions.246
Information provided to parents is in accordance with this legislation. 247 However,
practitioners are provided with information and refusal forms, to be used if parents refuse
consent. 248 Even though the legislation allows no exceptions, in practice exceptions are
permitted.
237 For example, breach of a statutory duty or negligence may be available torts. Most states have a policy requiring written refusals where parents refuse consent, to reduce potential liability of health providers. 238 The scope of parental duties in the tort of negligence is beyond the scope of this dissertation. 239 By comparison, New Zealand has an opt-in system requiring consent for testing. 240 Forty states require written refusal. The others, for example, Colorado, Georgia, Massachusetts, Iowa and Florida, all require a written record on the child’s file. Elaine H Hiller, Gretchen Landenburger, and Marvin R Natowicz, “Public Participation in Medical Policy-Making and the Status of Consumer Autonomy: The Example of Newborn-Screening Programs in the United States” (1997) 87 American Journal of Public Health 1280, 1281. 241 Iowa Code §136A.5(3) (2005). 242 Fla Stat §383.14(4) (2006). 243 Hiller (1997), 1286. 244 See for example Georgia: Ga.Comp.R. & Regs.r. 290-5-24.02(1) (2006), and Massachusetts: ALM GL ch. 111, § 110A (2006). 245 KRS § 214.155(4) (2006). 246 S.D. Codified Laws § 34-24-17 (2006). 247 South Dakota Department of Health Newborn Screening Programme, Newborn Screening, Tests That Could
Save Your Baby’s Life, South Dakota Department of Health, 2005, online at http://www.state.sd.us/doh/NewbornScreening/index.htm accessed 5 October 2006. 248 South Dakota Department of Health Newborn Screening Programme, South Dakota Newborn Metabolic
Screening Practitioners Manual, South Dakota Department of Health, 2005, online at http://www.state.sd.us/doh/NewbornScreening/NMS_Guide.pdf accessed 5 October 2006, 6-8.
30
NBS is given statutory force in the USA, to ensure that health providers test as many children
as possible. The legislation does not significantly intrude on parents’ rights, as they have a
right to refuse the test in all states. In practice however, only thirteen states require that
parents are given information before the test and even less require that parents be informed
that they have the right to refuse the test.249
In New Zealand, informed consent must be sought from parents prior to testing. Parents have
a right to complain if informed consent is not obtained, as evidenced by the HDC’s decision in
respect of a child born at National Women’s Hospital.250 New Zealand is different to the
majority of states in the USA in this respect. Practically though, the differences between the
jurisdictions are limited. As highlighted by the Privacy Commissioner251 and HDC,252 the
procedures ensuring parents give true informed consent to NBS are “patchy at best” in New
Zealand.253 It is therefore probable that many New Zealand parents are also unaware of their
right of refusal.
If New Zealand were to adopt an approach similar to the USA, there would be little practical
change from the procedures currently used. Even if the exceptions were limited to religious
objections, depending on the way such an exemption was framed, those who wished to object
could quite easily bring themselves within that exception. It is therefore necessary consider
alternative ways of making NBS mandatory.
3.2 A Unique Alternative: Placing Duties on Both Parents and Health Providers
Another option is to place a positive statutory duty on parents to have their child screened,
allowing no exceptions.254 This would require some method of enforcement, for example, by
imposing criminal liability on those who refuse NBS. This duty should require parents to
make their child available for testing.
Introducing mandatory NBS does not mean that parents should not be informed. The aim of
mandatory screening is not to keep parents in the dark, but to protect children from harm. It is
unlikely that Parliament would pass mandatory NBS legislation without some requirement to
inform parents. An example of Parliament’s reluctance to remove consent requirements
completely can be seen in the Mental Health (Compulsory Assessment and Treatment) Act
1992. Even where the Act authorises treatment without consent, where practicable, consent
249 Hiller (1997), 1281. 250 HDC Case Number 99HDC09011, 4 August 2000. 251 Privacy Commissioner (2003), 11. 252 HDC case number 99HDC09011, 4 August 2000. 253 Privacy Commissioner (2003), 11. 254 It would be necessary to state that, where the health and safety of a child would be compromised by a NBS test, that child should not be tested until it is safe to do so.
31
must first be sought from patients.255 Informing parents serves a number of useful purposes.
Parents may be aware of a family history that makes it important to test the child as early as
possible.256 If parents understand the procedure they are also less likely to be anxious about
the health of their child.257
In order to ensure parents can fulfil their duty, it is necessary that health providers have a duty
to ensure that parents are aware of NBS, and make it possible for the tests to be carried out.
The rationale behind imposing sanctions on parents would be to ensure all children are
screened. However, many parents, particularly first time parents, may be unaware that NBS is
available or required by law. If health providers fail to inform them, parents will be criminally
liable for failing to perform a duty they knew nothing about. This would be an ineffective way
of ensuring screening. Therefore, it is appropriate to place a duty on health providers to
inform parents, as they have the necessary knowledge and are in the best position to arrange
testing. Health providers should be subject to disciplinary proceedings for failing to discharge
this duty.
The following sections of this dissertation will consider the appropriateness of a mandatory
NBS system, allowing no exceptions and imposing criminal sanctions on parents for failure to
comply, but requiring health providers to inform parents about the procedure.
4. Goals of a Mandatory Screening Programme
For mandatory NBS to be appropriate in New Zealand, it would need to achieve more than the
current system. This dissertation will deal with two primary goals. Firstly, mandatory NBS
would aim to increase the coverage of NBS so that no child misses out on a test. Secondly,
mandatory NBS would aim to increase the number of affected children diagnosed early. It is
not appropriate to implement a mandatory screening programme unless it would achieve these
goals. The factors in favour of mandatory screening must also outweigh the factors against.
5. Factors in Favour of Mandatory Newborn Screening
5.1 Benefits for the Child
NBS is clearly in the best interests of all children.258 There is virtually no risk involved in the
procedure and the potential benefits are substantial. Children, who would otherwise have been
confined to a lifetime of mental retardation and physical disability, are able to function and
develop like normal children. Mandatory screening would, in theory, ensure all children
received a NBS test, and therefore that all affected children receive the benefits of early
255 Section 59(4) Mental Health Act (Compulsory Assessment and Treatment) Act 1992. This includes patients subject to compulsory treatment orders. Section 67 of the Act also requires that every patient be have the possible effects of any treatment explained to them before that treatment. 256 Faden (No2) (1982), 1398. 257 Faden (No2) (1982), 1398. 258 See chapter one of this dissertation. See also NWHB
32
diagnosis. This is the most compelling reason for making NBS screening mandatory. Even if
only a small number of children benefit from mandatory NBS, this supports introducing the
scheme, because the benefits are so huge.
5.2 Benefits for the Family
NBS benefits the family group in a number of ways. Firstly, living with a mentally or
physically disabled child can be extremely stressful for parents and siblings. NBS reduces this
stress by preventing or reducing the child’s disability. Affected children do need careful
monitoring to ensure they follow their treatment plan closely. However, this is arguably less
stressful than providing a seriously disabled child with lifetime care.
NBS can also confer direct health benefits on an affected child’s younger siblings. NBS alerts
parents to the fact they are both carriers for a disorder. This allows them to be particularly
careful during any subsequent pregnancies. For example, some clinicians suggest that a
pregnant woman should follow a strict galactosaemic diet during pregnancy to reduce the level
of disability in a galactosaemic child.259 Parents can also take steps to ensure that diagnosis of
subsequent children occurs as soon as possible, either by prenatal diagnosis, or as soon as
possible after birth. Such steps increase the likelihood that a child will develop normally.
5.3 Reasons of the State
(a) Policy Reasons
The World Health Organisation (WHO) has stated that NBS should be mandatory and free of
charge, provided early diagnosis and treatment will benefit the newborn.260 This observation
was made in recommendations intended as a guide for genetics professionals and public health
officials when developing policies and practices. 261 A recommendation by a leading
international body should be given weight when considering an appropriate policy in New
Zealand.
(b) Economic Considerations
Health funding is limited, so it is important that screening is cost effective. Studies have
shown that it is more cost efficient to detect affected children by NBS, and treat them with life
long therapies,262 when compared with the cost of lifetime treatment for children who are
259 Note though that the benefits from such restriction are far from conclusive. For more information see Cornelis Jakobs, et al, “Dietary Restriction of Maternal Lactose Intake Does Not Prevent Accumulation of Galactitol in the Amniotic Fluid of Fetuses Affected with Galactosaemia” (1988) 8 Prenatal Diagnosis 641. 260 Proposed International Guidelines on International Issues In Medical Genetics and Genetic Services, WHO/HGN/GL/ETH/981 (World Health Organisation, Geneva, 1998), 7 (WHO No1) and Dorothy C Wertz, J C Fletcher, and K Berg, Review of Ethical Issues in Medical Genetics: Report of Consultant to WHO, WHO/HGN/ETH/00.4 (World Health Organisation, 2003), 39 (WHO No2). 261 WHO No2 (2003), I. 262 The treatments involve either dietary restrictions or drug based treatments.
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diagnosed clinically.263 Tandem mass spectrometry is generally even more cost-saving than
current methods of testing.264 NBS is most efficient when all affected children are identified
using NBS, rather than by clinical diagnosis. If mandatory NBS could increase the number of
affected children detected by NBS, then this would support implementation of such a policy.
5.4 Conclusion
The main reason for introducing mandatory screening is that the potential benefits of NBS are
enormous, and should be available to all newborns. NBS also reduces the impact of a disorder
on the family unit and the cost to the State of treating these children. Finally, international
policy guidelines support mandatory NBS.
6. Reasons against having a mandatory scheme
Mandatory NBS must be considered in a New Zealand context. Despite the benefits of NBS,
there are a number of factors which indicate that mandatory NBS may not be appropriate in
New Zealand.
6.1 New Zealand’s current compliance rate.
(a) Would Mandatory Screening Increase Coverage?
The primary aim of mandatory screening is to ensure that every child receives a NBS test. As
99% of newborns are screened under the current voluntary system, it is arguable that NBS is
effectively compulsory already. It is also doubtful that 100% coverage is even possible.265
Making screening mandatory may therefore be unnecessary.
While 99% coverage indicates that New Zealand’s NBS programme is effective, in absolute
terms, a reasonable number of children are still missed.266 However, parental refusal is not the
only cause. For example, home births, early hospital discharge, being born outside of the area
where the parents reside, and being moved to a special care unit, are all factors that increase
the risk of a child not being tested.267 These factors result in more unscreened children than
parental refusal. Therefore, removing parents’ right to refuse NBS would not necessarily
ensure that all newborn are tested.
If introducing mandatory screening would not increase the percentage of children screened
then it is unlikely to be appropriate in New Zealand. Improving procedures in relation to
263 Aaron E Carroll, and Stephen M Downs, “Comprehensive Cost-Utility Analysis of Newborn Screening Strategies” (2006) 117 Pediatrics S287, S294. 264 Carroll (2006), S294. 265 As discussed below, parental refusal is only one reason that children are not screened. 266 If 1% of 60,000 newborns are missed, this amounts to 600 children. 267 Donald W L Spady, Duncan Saunders, and Fiona Bamforth, “Who Gets Missed: Coverage in a Provincial Newborn Screening Program for Metabolic Disease” (1998) 102(2) Pediatrics e21, 5 Electronic Article, pages renumbered starting at 1, available online, http://www.pediatrics.org/cgi/content/full/102/2/e21 at 5 October 2006.
34
transferring newborns, and screening children who are delivered at home, may be a more
effective way to increase the number of children tested.
(b) Would More Affected Children Be Detected Early?
The second goal of mandatory NBS is to increase the number of affected children who are
diagnosed by NBS.268 In theory, if every newborn was tested then all affected children should
be diagnosed by NBS. It has been reported that the risk of missing a child with PKU, because
of a failure to screen, is considerably less than the risk of missing a child because of a false
negative test result.269 If true, this would provide a strong argument against mandatory NBS,
because it would be unlikely to increase the percentage of affected children identified using
screening.
However, these statistics are based on older technology. Studies show that tandem mass
spectrometry is more accurate than other screening methods.270 In one research centre,271 after
screening more than 550,000 babies using tandem mass spectrometry, there have been no
known false negative results for PKU.272 With highly accurate technology, 100% of all
affected children can be diagnosed using NBS.
However, as the current coverage rate is so high, mandatory NBS is unlikely to increase the
absolute numbers of children diagnosed using NBS. A mandatory system would only achieve
this second goal, if the percentage of parents consenting to NBS drops.
(c) Risk That Compliance Will Drop
The high compliance rate in New Zealand is a strong factor leaning against mandatory
screening. However, there is no guarantee that in New Zealand this will always be the case.
If only 70% of parents were consenting to NBS, a mandatory scheme could help increase the
number of children tested.
There is a growing concern in New Zealand regarding privacy issues created by NBS. In 1995
there were no requests by parents for the return of a child’s NBS card.273 However, by 2002
268 This is as opposed to relying on clinical diagnosis. 269 See chapter one for an explanation of false negative results. Faden No1 (1982), 1351 states, with regard to the state of Maryland, that “the chance of missing a PKU infant at the observed rate of parental refusal (0.05 per cent) is 100 times less than the chance of missing a PKU infant because of a false negative test result.” This was quoted in a New Zealand context in Jones (2000), 23. 270 For more information on why this technology is more accurate. see Chace (1998). Pediatrix Screening website, Pediatric Medical Group, Tandem Mass Spectrometry at http://www.pediatrix.com/body_screening.cfm?id=343 accessed 6 October 2006. Note also, that this technology is soon to be introduced in New Zealand. 271 That research centre being ‘Neo Gen Screening.’ This is now part of ‘Pediatrix Screening,’ one of the largest newborn screening centres in the USA. 272 Chace (1998), 2409. 273 These are stored indefinitely following testing but can be returned to parents by request. Many parents are not aware of this right: Privacy Commissioner (2003), 10.
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the numbers had risen steadily, with parents requesting the return of 775 NBS cards.274 Both
the Privacy Commissioner 275 and the HDC 276 have expressed concern about the lack of
regulation for the collection and use of NBS cards. In his 2003 report, the Privacy
Commissioner stated that “New Zealand appears to have a voluntary screening scheme which
has worked well, but its uptake is vulnerable to a decline in trust.” Stored NBS cards have
been released to third parties in a variety of circumstances. 277 The Commissioner was
concerned that the lack of clear rules preventing the use of NBS cards, for reasons other than
NBS, could already be leading to a lack of faith in the NBS system, as indicated by the
increase in requests for the return of NBS cards.278
In an investigation following H v G,279 the HDC noted a number of problems with the
procedures for obtaining informed consent.280 There, no one had obtained informed consent
from the mother because all those involved thought that the responsibility for doing so lay
with someone else. In many cases information was not getting to parents meaning that many
would not have been aware that they could refuse NBS. For example, the distribution of a
NBS information leaflet281 appeared to be erratic.282 This leaflet has also been criticised for
being misleading, because screening is presented as something that will happen and does not
highlight the fact that parents are able to refuse consent to this test.283
In response to the HDC recommendations, Auckland Healthcare modified its procedures to
require informed consent to be recorded. More parents are therefore being given the chance to
give real informed consent. Although, as noted in the Privacy Commissioner’s report, there
have been no steps taken to improve consent procedures at a national level.284 Improved
informed consent procedures, combined with a decrease in trust, may result in more parents
exercising their right to refuse NBS.
274 Privacy Commissioner (2003), 6. Figures were provided by the National Testing Centre. 275 Privacy Commissioner (2003), 10. 276 HDC case number 99HDC09011, 4 August 2000. 277 For example, in the murder trial of Mr Scott Watson, NBS cards were used to identify evidentiary samples as belonging to missing victims Olivia Hope and Ben Smart: Jones (2000), 22. The court has also ordered that they be used for DNA testing in paternity cases: H v G unreported, HC Auckland M, 1868/98, May 1999, Salmon J (No1), H v G (1999) 18 FRNZ 572 (No2). 278 Privacy Commissioner (2003), 11. 279 H v G (No1), and approved in H v G (No2). 280 HDC Case number 99HDC09011, 4 August 2000. In this case the Auckland District Health Board was found to have breached the Code of Rights by not obtaining informed consent from a mother before a NBS test. 281 National Testing Centre, Your Newborn Baby's Blood Test: Te Whakamātau Toto O To Peepi Hōu, National Testing Centre, Ministry of Health, Auckland, 2004, online at file:///C:/Documents%20and%20Settings/Acer/My%20Documents/Dissertation/Chapter%20One/Newborn%20screening%20leaflet%20NZ.htm accessed 5 October 2006. 282 HDC Case number 99HDC09011, 4 August 2000, 9. The commissioner noted that not all maternity carers had seen the pamphlet or distributed it to their patients. 283 Jones (2000), 23. 284 Privacy Commissioner (2003), 11.
36
(d) Conclusion: New Zealand’s Current Compliance Rate
Mandatory NBS is not appropriate at this time because we currently have virtually 100%
coverage. But, if the percentage of children being tested were to decrease significantly, the
case for mandatory screening would be considerably stronger. Mandatory NBS may be
required to reverse a decline in the number of children tested. However, even if compliance
drops there are a number of other risks associated with mandatory NBS, which are addressed
in the remainder of this chapter.
6.2 Risks for the Child
(a) Parental Fear of Prosecution and Health Providers
It is easy to assume all parents will abide by mandatory NBS legislation. However, as seen in
some medical treatment cases, placing a legal obligation on parents to provide a child with
treatment, does not guarantee that they will actually do so. A New Zealand example can be
seen in Healthcare Otago Ltd v Williams-Holloway. 285 Liam was placed under the
guardianship of the court, which consented to him receiving chemotherapy, against the wishes
of his parents. Despite the Court order, the parents went into hiding to prevent Liam from
receiving chemotherapy.
The risk of a child suffering harm without NBS is remote. Parents may therefore be even less
concerned about breaching mandatory NBS laws, when compared with treatments such as
chemotherapy. Forcing parents to break the law if they do not want their child screened,
places the child in danger for a number of reasons.
One of the main factors in support of mandatory testing is that it is in the best interests of the
child to ensure they are healthy. If parents, in breach of any statutory regime, do not have the
child screened, fear of criminal conviction may keep them from taking the child to the doctor
in the future. If a child begins to show symptoms of a NBS disorder or any other illness, but
parents delay taking them to the doctor, the child could be worse of than if a mandatory
scheme had not been in place. It is therefore arguable that mandatory screening is not
appropriate because it could create a barrier between health providers and parents, resulting in
harm to the child.
(b) Let Sleeping Dogs Lie
For most parents, NBS is a small detail in the week following the birth of their child. It is
possible that most parents, when told NBS is for the benefit of their new child, agree to the test
without much consideration of their right to refuse consent. Introduction of mandatory NBS
legislation could not be done without attracting media attention. This may draw attention
away from the medical reasons for the test, and focus attention on the removal of parents’
rights. A small number of parents, who previously would have consented, may object to NBS
285 The child, Liam, was 3 years old and suffering from a child cancer called neuroblastoma.
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because it is made compulsory by the State, rather than because they actually object to NBS.
Some parents are already fearful of the use of NBS cards for purposes other than NBS.286
Mandatory screening may inflame these views. If this leads parents to avoid NBS, despite any
enforcement provisions, this places children at risk of harm.
6.3 Risks for the Family
The primary objection to mandatory NBS is that it interferes with the parental and family
rights to make decisions about the medical treatment of children. Chapter four will deal
specifically with this concern and whether mandatory NBS is a justifiable limit on this right.
The mandatory scheme being considered imposes criminal sanctions for parents if their child
is not tested. Any criminal liability is serious and should not be imposed lightly, as it can have
far-reaching consequences for the parents and family. It could be argued that imposing
criminal liability is out of proportion to the crime. It is unlikely that parents will be liable
under section 152 of the NZCA for failing to screen, even where a child suffered harm.287 It
would therefore seem strange to impose criminal liability for failing to take this precaution,
where a child does not suffer harm.
6.4 Reasons of the State
(a) Policy Reasons
The Human Genetics Society of Australasia (HGSA) has stated that NBS should not be
mandatory.288 The HGSA is a body that considers and comments on matters relevant to
human genetics in New Zealand and Australia. It represents this field in public, professional,
and governmental forums.289 Their position conflicts with that of the WHO, but the HGSA
gives no reason for this different approach. As a local body it may become involved should
Parliament attempt to make NBS mandatory in New Zealand. For this reason its position is
relevant.
(b) Economic Considerations
The Wilson-Junger screening criteria recognise that the cost of diagnosing and treating
patients should be economically balanced in relation to possible expenditure on medical care
as a whole.290 NBS has been demonstrated to be a cost-effective scheme.291 However, a
286 See Privacy Commissioner (2003), 9 where he outlines privacy concerns raised by NBS and gives examples of political discussion centred on the used of Guthrie cards. 287 See chapter two, section 5.1. 288 Human Genetics Society of Australasia, Royal Australian College of Physicians Newborn Screening Joint Subcommittee, HGSA Policy Statement: Newborn Blood-spot Screening (2004) Human Genetics Society of Australia, 3. 289 Human Genetics Society of Australasia, Mission Statement, online at http://hgsa.com.au/Index.cfm?pid=111125 accessed 7 October 2006. 290 Principle number 9, Wilson (1968), 27. See chapter one of this dissertation for a brief discussion of these criteria.
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mandatory scheme may generate extra costs because parents who refuse tests would need to be
found and prosecuted. If the cost of NBS increased significantly because of enforcement costs,
a mandatory scheme may not meet the Wilson-Junger screening criteria.
As only a few parents currently refuse consent, the added expense of enforcement will be
small. The increase in cost may not prevent NBS from being a cost-saving programme.
However, the increase in expenditure is unlikely to result in money being saved by early
diagnosis and treatment. Only a handful of extra children would be tested and even fewer
extra affected children would be identified. Further statistical analysis of the costs and savings
would need to be completed before any mandatory screening programme could be introduced,
to ensure its economic viability.
7. Conclusion
Mandatory NBS is not necessary in New Zealand because our current compliance rate is so
high. It would not increase the percentage of children tested or the number of affected
children diagnosed by NBS. Mandatory screening may even be counter-productive, as
objections to state interference could lead to a reduction in compliance. There is therefore no
case for mandatory NBS in New Zealand at present.
If the compliance rate were to drop to 70%, there would be a stronger case for mandatory NBS.
The criminal sanctions would be likely to persuade a significant number of those who would
otherwise refuse consent, to do so. However, even if this were the case, there are other risks in
introducing mandatory NBS. For example, parents who are afraid of a criminal conviction
may delay taking a sick child to the doctor, which is contrary to the child’s interests. The
increased costs of enforcement may also outweigh any benefit to the State. Serious
consideration would therefore need to be given to these concerns before adopting a mandatory
screening programme.
291 Carroll (2006).
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Chapter Four: Is Newborn Screening a ‘Justified Limitation’?
1. Introduction
This chapter examines whether mandatory NBS is a justified limitation on the rights of parents.
Chapter three concluded that mandatory screening would not be appropriate in New Zealand
now, but a change in circumstances might make mandatory screening an effective option.
However, this does not mean that introducing mandatory NBS would be a justified limitation
on parents’ rights.
Chapter two explained that the risks parents can expose their children to are not clearly
defined. This chapter considers whether the risks associated with not screening, justify
Parliament in introducing mandatory NBS legislation. This involves briefly outlining the
rights of affected parties and comparing NBS with other situations where Parliament has
limited parents’ rights.
2. Rights and Interests at Stake
2.1 Rights of the Child
(a) The Right to Life and Adequate Health Care
The most basic right is the right to life,292 which is explicitly recognised in section 8 of
NZBORA.293 The personal rights of parents, for example, to manifest their religious beliefs,
do not extend to refusing consent to life saving treatment, where to do so will deny a child’s
right to life.294 As the risk of any damage from failing to screen is remote, it is unlikely that
refusing NBS is a violation of the right to life.295 Other rights must therefore be identified to
support a mandatory screening programme.
In Article 6(2) of the United Nations Convention on the Rights of the Child 1989 (UNCROC),
State Parties agree to “ensure to the maximum extent possible the survival and development of
the child.” Article 24 provides that children have a right to “the enjoyment of the highest
attainable standard of health and to facilities for the treatment of illness.” Delayed treatment
of NBS disorders leads to irreversible mental retardation or serious physical defects.
Therefore, allowing parents to refuse NBS does not ensure a child’s right to survival,
292 This is not an absolute right of children or adults. See for example Auckland Healthcare Services Ltd v L & L [1998] NZFLR 376 and Auckland Area Health Board v Attorney-General [1993] 1 NZLR 235. The court will not compel doctors to provide life saving treatment where this is not in the best interests of the child, although this is a rare occurrence. 293 This right is also specifically recognised in relation to children in Article 6(1) of the United Nations Convention of the Rights of the Child 1989. 294 See for example Re J (CA). 295 Newson (2006), 135.
40
development, and enjoyment of the highest possible standard of health. This interpretation is
supported by the WHO’s position, that NBS should be mandatory because newborns are
vulnerable and deserve special protection.296 UNCROC could therefore be interpreted as
requiring State Parties to implement a mandatory scheme.
(b) The Right to an Open Future
A child possesses the right to make decisions for his or her self. However, as a newborn is
unable to exercise rights of free choice, they are held on trust until they have that capacity.297
This is sometimes called the ‘right to an open future.’298 Parents have an obligation not to
interfere with a child’s right to make autonomous decisions in the future.299 This right can be
violated before the child is able to exercise it. For example, if a parent does not consent to
NBS and a child suffers irreversible mental retardation, the child will be incapable of
exercising rights of personal autonomy in a wide range of circumstances. 300 Screening and
early treatment gives a child the best chance of developing into a competent adult, capable of
make their own decisions. It is therefore the best way to ensure that the child has an open
future. In the unlikely event that the child regrets the parents’ decision to test or treat them for
a disorder, they are able to exercise their right to refuse further medical treatment.301 The long
term outcome may well be similar,302 but the child has not been denied the right to make such
a choice.
2.2 Interests of the State
Chapter three highlighted the state’s need to provide quality health care in the most effective
and cost-efficient way. NBS is a cost-efficient healthcare policy. If mandatory NBS could
make NBS more cost-efficient, the state has an interest in adopting such a policy.
2.3 Rights of Parents as Guardians
(a) Right to Consent on Behalf of a Child
Chapter two outlined the rights of parents to make decisions for their children, the duty to act
in the child’s best interests and what this entails in some detail. Commentators, both
supporting and opposing mandatory NBS, agree firstly, that parents have a right, although not
absolute, to consent to medical treatment for their child and secondly, that this right exists to
296 WHO No2 (2003) 39. The WHO is the United Nations specialist health body. 297 Joel Feinberg, “The Child’s Right to and Open Future,” in W Aitkin and H La Follette (eds), Whose Child?
Children’s Rights, Parental Authority, and State Power (Rowman and Littlefield, Totowa, New Jersey, 1980) 124, 124. 298 Feinberg (1980), 126. 299 Newson (2006), 139. 300 Feinberg (1980), 126 and Faden No2 (1982), 1397. 301 As guaranteed by section 11 of the New Zealand Bill of Rights Act 1990. This will only apply when the child is ‘competent’ to do so. 302 For many of the disorders, stopping treatment leads to disastrous consequences. Although, stopping treatment in adulthood may not cause as much harm as failing to treat at an early age.
41
enable children to develop and exercise their own autonomy. 303 However, there is still
disagreement about whether the State should override this right by requiring NBS. This is
considered below.
(b) Right not to know
The individual’s ‘right not to know’ genetic information about themselves has been upheld in
a number of legal and ethical instruments,304 such as the UNESCO305 Universal Declaration on
the Human Genome and Human Rights, 306 and the WHO’s Review of Ethical Issues in
Medical Genetics.307 This right is based on the right to autonomy or self-determination.308
When competent adults refuse medical treatment this must generally be respected no matter
how irrational the decision may seem.309 This is supported by section 11 of the NZBORA
which states that every person has the right to refuse medical treatment. A competent adult
must give informed consent before any carrier test is done using their own blood.310 As the
NBS disorders are largely inherited disorders, if a child returns a positive result,311 the parents
will usually both be carriers for the disorder.312 Mandatory NBS effectively removes the
parents’ right not to know their genetic composition, because the test results also establish
whether the parents are carriers. The right not to know may be overridden where there is a
risk of serious harm to others.313 It is arguable that it is appropriate to do so here because
without NBS a child risks serious and irreversible harm.
3. What is a Justified Limitation?
Deciding if a legislative provision imposes a justified limitation on the rights of citizens is
different to the analysis undertaken by the courts when exercising guardianship powers. The
rights in the NZBORA are subject to reasonable limitations that can be justified in a free and
democratic society. The NZBORA does not explicitly recognise a right to consent to medical
303 George J Annas, “Mandatory PKU Screening: The Other Side of the Looking Glass” (1982) 72(12) American
Journal of Public Health 1401, 1402. 304 R Andorno, “The Right Not to Know: An Autonomy Based Approach” (2004) 30 Journal of Medical Ethics
435, 436. 305 United Nations Educational, Scientific and Cultural Organisation. 306 Universal Declaration on the Human Genome and Human Rights, adopted by the General Conference of UNESCO at its 29th session on 11 November 1997. 307 WHO No2 (2003). 308 Andorno (2004), 435. Note, this is one possible basis for the right not to know. Some commentators argue that the right does not, or should not exist at all and others argue that it is based on other rights such as the right to privacy. See for example the response to Andorno (2004) in Laurie, G “A Response to Andorno” (2004) 30 Journal of Medical Ethics 439, 439 (No2). 309 This was stated clearly in St George’s Healthcare National Health Service Trust v S; R v Collins & Ors ex
parte S [1998] 3 All ER 673, 685. This right is also clearly stated in Right 7 of the Code of Rights. 310 A carrier test determines whether a person, who does not suffer from a genetic disorder, carries one copy of a defective gene which could be passed on to offspring. 311 This refers to true positive results as opposed to false positive results discussed elsewhere in this chapter. 312 See appendix one for details on the means of inheritance of all the disorders. 313 Andorno (2004), 437. This will usually be family members. Some commentators argue that it is not always straightforward to determine where this is appropriate. See Laurie No2 (2004) for more discussion on this point.
42
treatment on behalf of a child.314 Nevertheless, the approach taken to defining ‘justified
limitations’ in a NZBORA context provides a basis for deciding whether mandatory NBS is a
justified limitation on parents’ rights.
The courts have held that this analysis requires determining the objective of the legislation,
and whether limitation is proportional to the importance of that objective.315 Any limitation
should involve as little interference with the affected right as possible.316 The primary goal of
mandatory NBS legislation would be to increase the percentage of children screened. 317
Mandatory screening would only be justified if this could be achieved.318
Mandatory NBS must also be a reasonable way to achieve this objective. In Moonen,319 the
Court held that defining a justified limitation is ultimately a matter of judgement requiring an
analysis of all social, legal, moral, economic, administrative, and ethical considerations.320
The rest of this chapter analyses whether mandatory screening legislation is a proportionate
response to the object of ensuring all children receive a NBS test, with these considerations in
mind.
4. Previous Statutory Intervention on Parental Rights
It is useful to start by considering other examples of State intervention. Parents can expose
their children to some risk. However, Parliament has legislated in a number of areas to control
parents’ decisions. For example, all cyclists must wear a securely fastened helmet. 321
Previously, parents could control whether their child wore a helmet.322 Parents could therefore
place their child at risk of brain damage from a cycling accident. Parliament found this
inappropriate and now requires everyone, even adults to wear a helmet.323
314 Some parents have argued that overriding parents’ right to consent to medical treatment limits their right to manifest their religious belief as protected by section 15, NZBORA. See for example Re J (CA). If parents refuse NBS on religious grounds this section might be relevant. However, unlike blood transfusion cases, the reasons for refusing NBS are not necessarily religious. See NWHB and HDC case number 99HDC09973 where no religious objections were put forward by parents for refusing NBS. 315 Moonen v Film Literature Board of Review [2000] 2 NZLR 9, 16; Hopkinson v Police [2004] 3 NZLR 704, 711. 316 Moonen, 16, per Tipping J; Hopkinson, 711, per France J. 317 See chapter three, section 4 for an outline of the goals of mandatory screening. The benefits of NBS and the reasons for having a child screened have been highlighted in earlier chapters. 318 As outlined in chapter three, this is not the case at present. This discussion of whether the limitation is justified would only be relevant if a change in circumstances meant that NBS would be effective in New Zealand. 319 Moonen v Film Literature Board of Review [2000] 2 NZLR 9, 17. 320 Moonen, 17 per Tipping J. 321 Land Transport (Road Users) Rule 2004, rule 11.8. This rule was introduced in New Zealand in 1993 in section 38A of the Traffic Regulations 1976. 322 In practice parental control in this area would have got less as the child got older. 323 This is enforced by a $55 infringement fee for those who do not comply: Land Transport (Offences and Penalties) Regulations 1999, Schedule 1.
43
Parliament also requires all children under the age of five to be restrained by an approved
child restraint when travelling in a vehicle.324 In practice, this limits the power of parents to
expose their child to the risks associated with travelling in a car without a proper child
restraint.325 More generally Parliament also requires everyone travelling in a car to wear a
seatbelt.326 This is a further restraint on parents’ rights to expose their children to risks.327
These limitations are imposed to reduce the risks associated with travelling on bikes or in cars
and reduce the harm suffered by individual children and adults.
5. Comparison of NBS with Other Statutory Limitations
5.1 Benefit to the State and Individuals
In each of the above examples328 the State compels parents to take safety precautions they
might not otherwise have taken. A large percentage of children would never have suffered
serious harm if these laws were not in place, because many would never have been in a serious
accident. For the small number of children who will be involved in an accident, the chances
of making a full recovery are increased by using child restraints, seat belts, and cycle helmets.
These rules help protect the child’s right to an open future and their right to have their survival
and development ensured to the maximum extent possible.
It is also in the State’s economic interests that these laws are enforced. The State may have to
pay for some treatment following an accident, but the overall cost is likely to be less than if
the use of such protective measures was not compulsory. This legislation therefore benefits
the State and its citizens generally, as well as a smaller number of individuals personally.
A similar argument can be made in relation to NBS. The risk of any particular child having a
disorder is slim, but compulsory screening reduces the chance of any child suffering life
threatening and long term complications from a disorder, should the risk eventuate. If less
money is spent treating these children, the money saved is available for other State funded
programmes. Therefore, mandatory NBS also provides benefits to the State generally as well
as a small number of affected children.
This feature distinguishes NBS from some situations where parents are allowed to expose their
children to risks. For example, when parents let a child get their ears pierced, the cost to the
State if something goes wrong is likely to be small, and does not warrant interference. Other
parental decisions can affect the state more directly, such as where parents feed their children
unhealthy food, leading to increased spending on cardiovascular disease. However, situations
324 Land Transport (Road Users) Rule 2004, rule 7.6. If this rule is not followed, the driver can receive a fine of $150: Land Transport (Offences and Penalties) Regulations 1999, Schedule 1. 325 This is because it is generally parents, or guardians of a child that carry children in a car. 326 Land Transport (Road Users) Rule 2004, rules 7.8, 7.9, and 7.10. 327 This is also an area where the parents’ personal rights are limited. 328 Cycle helmets, child restraints, and seat belts.
44
like this are much harder to control. For example, how much is too much food? What food
should not be given to children at all? There are too many differences between each child, and
types of food, for the State to effectively control diets to prevent childhood obesity.
NBS cards are also a potential source of DNA.329 This could be a valuable resource for
fighting crime and could therefore provide further benefits to the State. NBS cards are not
currently used to link an accused with a crime, but they have this potential.330 This raises a
number of concerns which are outside the scope of this dissertation but would need to be
considered when implementing mandatory NBS.
Mandatory NBS provides social, economic and administrative advantages to the State and
therefore society generally. This supports a claim that mandatory NBS is a justified limitation
on parents’ rights.
5.2 Using the ‘Blunt Instrument’ of the Law
It is often argued that the State should not control the decisions of parents unless a child’s life
is in immediate danger, because the law is a blunt instrument, incapable of coping with such
complex situations.331 In relation to many medical treatments this is accurate. Parents are
given the power to consent to medical treatment for their children because they generally
know more about the child’s needs than Parliament or the court. They have a personal interest
in the development of their child and are therefore the best equipped to make decisions on
behalf of the child.332 The court and the State should therefore be reluctant to interfere with
parental autonomy. However, it is arguable that the blunt instrument of the law can
adequately address NBS.
(a) Variability of Risk Between Children
In passing legislation requiring the use of child restraints, seatbelts, and cycle helmets,
Parliament is indicating that there are no particular circumstances where those rules are
inappropriate.333 The type of car you are in, the size of the car’s airbags, and the driver’s skill
in handling a car or bicycle are all irrelevant variables when applying these rules. Each time
someone wears a cycle helmet the circumstances are slightly different but the differences are
not material to whether the helmet should be worn.
329 See for example, H v G (No1), where a child’s NBS card was used for DNA paternity testing. 330 See the Memorandum of Understanding between the Ministry of Health and the New Zealand Police relating
to the disclosure of newborn blood spot samples and related information, in effect since 28 February 2006, clause 2.2, for a list of situations in which police may request access to samples. 331 Goldstein (1977), 650. 332 Caldwell (2000), 130. 333 There are some very specific exceptions in the legislation which are not relevant to this discussion.
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If some children would be better off without NBS then parental consent should be required.334
Conversely, if only one reasonable decision can be made, that is, to consent to a NBS test,
then mandatory screening is a justified limit on parental rights.335 As with child restraints and
cycle helmets, there are arguably no variables, specific to each child, which affect the
desirability of NBS. There are no reported cases of children experiencing complications as a
result of the NBS test itself.336 Regardless of the genetic make-up of the child, the risks
associated with NBS are the same. Newborns, as a group, also have the same risk of having a
disorder, despite their genetic differences. There is therefore no reason to deal with each child
on a case by case basis. There are a small number of children with an increased risk of having
a disorder, making them different to other newborns.337 However, the difference provides an
even more compelling reason for them to be tested and does not support the position that each
child should be considered separately.
In this regard NBS is different to other medical treatments, such as chemotherapy. The
effectiveness of chemotherapy varies depending on the type of cancer, how far it has advanced,
and other treatment the child has received. For every cancer patient, the prognosis is different
and it is impossible to direct on a global basis that all children who suffer from cancer be
given certain levels of chemotherapy. In each case there is often more than one reasonable
choice, so it is not appropriate for Parliament to intervene. 338
Mandatory screening is an appropriate use of the ‘blunt instrument’ of the law, because
parents have no special knowledge about their child that could affect whether NBS is in the
child’s interests.339
(b) False Positive Results
Those who oppose mandatory NBS, argue that it is too simple to say that there is only one
reasonable choice, because this fails to consider events after the test is completed. A large
majority of newborns will receive negative test results for all disorders and have no further
concerns. However, 1% of newborns will receive a false positive result.340 Such diagnoses
can quickly be identified and corrected with further tests. 341 Despite this, some studies
334 Faden No2 (1082), 1398. 335 Faden No2 (1982), 1397. 336 The only reported case of a baby being hurt in New Zealand involved a midwife accidentally using a cup of boiling water to warm the baby’s foot instead of a cup of warm water. This accident was not related to the safety of the NBS test but rather the negligence of the midwife concerned. For more information see HDC case number 00HDC06573, 3 April 2002. 337 The child could have a family history of the disorder, parents who are known carriers, or an older sibling who suffers from a disorder. 338 Where appropriate, the court can intervene under the guardianship jurisdiction to ensure a child is treated. See for example, Re Norma. 339 Faden No2 (1982), 1397. 340 Newson (2006), 140. See chapter one, section 5 for a description of false positive results. 341 Some of these tests can take a few days.
46
indicate that parents continue to be anxious about their child’s health long after the correct
diagnosis is made. 342 It is argued this anxiety leads to problems in the parent-child
relationship.343 However, this research has been criticised for not using proper control groups
or reliable sampling methods.344 It is therefore far from conclusive that children suffer any
long term harm from false positive results.
As more disorders are tested for using NBS, the chance of a child returning one false positive
result increases, meaning any risks associated with false positive results may become a bigger
problem.345 However, this concern fails to consider improvement in technology. Methods
such as tandem mass spectrometry now produce significantly less false positive results for
most disorders.346 Even if the effect of false positives is a valid concern, rejecting mandatory
NBS will not eliminate this problem. It is better to deal with this problem separately, rather
than overlook an affected child.347
(c) Variation in Clinical Outcome
For some NBS disorders there is a clear clinical outcome. For example, most PKU patients
who receive early and continued treatment have a particularly good outcome and are otherwise
normal people. For some disorders, such as galactosaemia and MSUD, the outcome is not so
predictable. Early treatment prevents death and many children do go on to lead valuable and
relatively normal lives, but this is not always the case. A significant number of children still
suffer from mental and physical problems even with early treatment. It could therefore be
claimed that there is not simply one reasonable decision to be made by parents.348
To an extent, disorders such as MSUD, are similar to cancer because each child responds to
treatment in a different way. However, unlike chemotherapy, NBS provides parents with the
information to determine the likely outcome for their child. It is not a treatment in itself.
Once this information is available, parents can then decide whether treatment is in the best
interests of their child. If it becomes clear that the child is likely to respond well to the
available treatment then this child has not been denied the right to grow and develop.
342 Paul (1999), 6. For a summary of the findings in a number of studies see J M Green, et al “Psychosocial Aspects of Genetic Screening of Pregnant Women and Newborns: A Systematic Review” (2004) 8(33) Health
Technology Assessment, chapter 9. 343 Annas (1982), 1402. 344 For example, the studies do not compare parental stress of parents with newborns who had false positive results and parents with newborns that received a correct negative result. Pollitt No1 (1997), 92. 345 Annas (1982), 1402. 346 See Chace (1998) for a full discussion on why this is the case. 347 Paul (1999), 5. 348 Re T provides an illustration of the difficulties of deciding whether treatment is reasonable. There, Court of Appeal and High Court differed on whether the likely medical prognosis for the child meant that refusing treatment was reasonable.
47
Supporters of mandatory screening have accepted that such a scheme may only be appropriate
for disorders where the results from early treatment are generally very good.349 Where,
despite NBS, there is still a significant chance of a child being seriously disabled, a claim that
parents have only one morally defensible option is not as strong.350 Some commentators have
suggested that the State should make screening mandatory for some disorders, such as PKU,
and require consent before screening for disorders where the outcome is more variable.351
This approach would respect the rights of the child to a degree, while preserving the rights of
parents to make choices for their child where there is arguably more than one reasonable
option. However, such an approach also poses practical problems. Most countries, including
New Zealand, operate on an all or nothing basis. It would be time consuming and therefore
costly to determine which tests are to be completed for each newborn. One of the rationales
for imposing NBS is that it is a cost-efficient health care programme. Increasing the available
options may reduce this efficiency. 352 This concern is particularly relevant with the
introduction of tandem mass spectrometry. All molecules of interest are measured in a single
test, making it difficult to efficiently test each child for a different combination of disorders.353
(d) Conclusion
The blunt instrument of the law can adequately cope with NBS, as consenting to this minor
procedure will always be in the best interests of the child. Any limit on parents’ right to
consent is therefore minimal and Parliament is justified in removing the parents’ right to
choose.
6. Vaccinations: An Example Where Parliament Has Not Intervened
The New Zealand public health system provides access to a number of vaccines against a
variety of diseases.354 The consequences of contracting these diseases vary but a number of
people, often children, die or suffer serious long term harm from diseases for which there is a
vaccine.355
Vaccinations are similar to NBS because they confer benefits on the individual vaccinated as
well as society more generally. More individuals benefit personally from vaccinations
compared with NBS, because vaccination protects against diseases which are more common
349 Faden No2 (1982), 1400. 350 This is arguably the case with respect to galactosaemia, MSUD, and cystic fibrosis. 351 Faden No2 (1982), 1400. 352 Faden No2 (1982), 1400. 353 For a simple explanation of the way that tandem mass spectrometer works see the Pediatrix Screening website, Pediatric Medical Group, Tandem Mass Spectrometry at http://www.pediatrix.com/body_screening.cfm?id=343 accessed 6 October 2006. 354 Ministry of Health, Immunisation Handbook 2006, Ministry of Health, Wellington, 2006, online at http://www.moh.govt.nz/immunisation.html accessed 29 September 2006. 355 For example, meningitis, measles, and influenza.
48
than the NBS disorders. 356 Effective immunisation schemes also prevent diseases from
spreading, in some cases almost eliminating them.357 This benefits the State by reducing the
costs associated with treating the disease.
Despite these benefits, vaccinations are not compulsory. NBS confers similar benefits but to a
smaller number of individuals. It could therefore be argued that it is also inappropriate for
NBS to be compulsory. Nevertheless, there is one important difference between NBS and
vaccinations. Most vaccinations have side effects that affect a proportion of the community,
meaning there are risks associated with the vaccinations themselves. The lack of risk involved
in NBS is a feature that supports mandatory screening, distinguishes it from vaccinations and
justifies adopting different approaches to these procedures.
7. General Slippery Slope Argument
Opponents of mandatory screening have also expressed a variety of ‘slippery slope’ arguments.
Firstly, it is feared that mandatory NBS will lead to state interference in other routine
procedures where to do so would be morally reprehensible.358 This so far does not appear to
have eventuated. Mandatory screening has existed in the USA for four decades without such a
result.
It is also arguable that mandatory screening makes it too easy to expand screening
programmes to include other disorders, with little analysis of the benefits and risks of testing
and early treatment.359 This could remove the right to consent, where to do so is unjustified.360
It is true that some disorders, for example cystic fibrosis, have been added to NBS
programmes where there was inconclusive evidence of any benefits from early treatment.
However, it is far from clear that mandatory screening is to blame for these developments.
New Zealand has an informed consent system, yet screens for similar disorders to parts of the
USA, where screening is mandatory. 361 Maryland, a USA model of informed consent,
currently tests for 32 disorders. This is more disorders than screened for in some states with
mandatory NBS. For example, Georgia currently screens for nine disorders. While there is
legitimate reason for concern about the addition of inappropriate tests to NBS programmes, it
is not clear that mandatory screening is responsible for this problem.
356 Of diseases that are less common, this is generally because the vaccination programmes have been so successful. For example, between 1914 and 1961 there were 10,000 cases of poliomyelitis (polio) in New Zealand. Once vaccines were introduced the virus was halted. There is now virtually full immunization in New Zealand. For more information see the Post-polio support society website, http://www.everybody.co.nz/page-c96b6b4a-fa1a-4c46-9672-e05c8a4a5376.aspx accessed 7 October 2006. 357 For example, poliomyelitis. 358 Faden No2 (1982), 1400. 359 Paul (1999), 4. 360 Paul (1999), 4. 361 New Zealand’s NBS programme will be even more similar to many states in the USA once screening is done using tandem mass spectrometry.
49
8. Conclusion
Parents have a right to consent to medical treatment on behalf of their child. However,
mandatory NBS is a justified limitation on this right. The objective of this legislation would
be to screen all children to protect them from harm. NBS is a proportionate response to this
objective. As in other situations where Parliament has limited parents’ rights, NBS confers
benefits on society generally as well as a small number of individual children. Mandatory
NBS would be a minimal intrusion on parents’ rights, as consenting to NBS is the only
reasonable decision for parents to make. This conclusion is weaker in relation to disorders
where, despite NBS, a good outcome is not guaranteed. However, children with these
disorders still derive substantial benefits from NBS and it would be impractical to make
screening mandatory for some disorders and not others. In introducing a mandatory scheme it
would be appropriate to address the effects of false positive results and regulation of additional
screening tests. These concerns are potentially valid but can be handled within a mandatory
system.
50
Conclusion
NBS identifies newborns with inherited metabolic diseases, and facilitates early treatment, to
prevent irreversible mental retardation and physical abnormalities. NBS benefits the families
of affected children, by reducing the child’s disability. It also benefits the State, by reducing
treatment costs. Because NBS confers substantial benefits on the child, their family and the
State, this dissertation has considered whether NBS should be mandatory.
The court is unlikely to use its guardianship jurisdiction to consent to NBS, to protect the best
interests of the child. The risks associated with a failure to screen are too remote to justify the
court overriding parental refusal. If a child has an increased likelihood of having a disorder, or
exhibits symptoms, the court may find that the child is in immediate danger and override the
parents’ refusal to consent. The courts may also impose criminal liability where a child, at
special risk of having a disorder, suffers harm because the parents refused consent to NBS.
NBS is a justified limitation on parents’ right to consent to medical treatment on their child’s
behalf, because the risk of harm is minimal, and the potential benefits for individual children
and society generally, are huge. This conclusion is weaker in relation to disorders where,
despite NBS and early treatment, a good outcome is not guaranteed. However, these children
still receive substantial benefits from early treatment, and it is impractical to make screening
mandatory for some disorders and not others.
Although mandatory NBS is a justified limitation on parents’ rights, New Zealand’s high
compliance rate means it is unnecessary at present to introduce mandatory NBS legislation.
Mandatory screening could even cause compliance to drop because of parental objection to
State interference.
There would be a stronger case for mandatory screening if the compliance rate dropped
significantly. However, mandatory screening raises a number of other concerns. Criminal
sanctions may place children at risk of harm, by creating a barrier between parents who refuse
consent and the child’s health provider. The state would also incur extra costs from enforcing
screening provisions. Careful consideration would need to be given to these issues before
implementing any mandatory screening programme.
Mandatory screening is a justified limitation on parents’ rights. However, there is no case for
mandatory NBS in New Zealand at present. Even if the compliance rate dropped, careful
analysis of the costs and risks for children would need to be undertaken before implementing
mandatory screening.
51
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Medicine & Child Neurology 481 Weetch, E, and MacDonald, Anita, “The Determination of Phenylalanine Content of Foods Suitable for Phenylketonuria” (2006) 19 Journal of Human Nutrition and Dietetics 229 Wilckin, Bridget, et al, “Screening Newborns for Inborn Errors of Metabolism by Tandem Mass Spectrometry” (2003) 348 The New England Journal of Medicine 2304 Wildeman, Sheila, Downie, Jocelyn, “Genetic and Metabolic Screening of Newborns: Must Health Care Providers Seek Explicit Parental Consent?” (2001) 9 Health Law Journal 61 Wolf, Barry, “Biotinidase: Its Role in Biotinidase Deficiency and Biotin Metabolism” (2005) 16 Journal of Nutritional Biochemistry 441 (Wolf No1) Wolf, Barry, et al, “Biotinidase Deficiency: Novel Mutations and Their Biochemical and Clinical Correlates,” (2005) 25(4) Human Mutation 413 (Wolf No2) Electronic article, numbered from page 1, online at http://www3.interscience.wiley.com/cgi-bin/abstract/11 0431219/ABSTRACT?CRETRY=1&SRETRY=0 accessed 6 October 2006 Woolford, Mark, “R v Laufau: Manslaughter Trial August 2000” [2001] Journal of the
Auckland Medico Legal Society 19
Papers and Reports American College of Medical Genetics, Newborn Screening Expert Group, Newborn
Screening: Toward a Uniform Screening Panel and System (Commissioned by the Maternal and Child Health Bureau, Health Resources and Services Administration, 2005) Human Genetics Society of Australasia, Royal Australian College of Physicians Newborn Screening Joint Subcommittee, HGSA Policy Statement: Newborn Blood-spot Screening (Human Genetics Society of Australia, 2004) National Screening Unit, Improving Quality: A Framework for Screening Programmes in New
Zealand (National Screening Unit, Ministry of Health, 2005)
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National Newborn Screening and Genetics Resource Centre National Newborn Screening
Status Report (National Newborn Screening and Genetics Resource Centre, Texas, USA, updated 25 September 2006) online at http://genes-r-us.uthscsa.edu/nbsdisorders.pdf# search=%22National%20Newborn%20Screening%20Status%20Report%22 accessed 5 October 2006 Ministry of Health, Immunisation Handbook 2006 (Ministry of Health, Wellington, 2006) online at http://www.moh.govt.nz/immunisation.html accessed 29 September 2006 Privacy Commissioner, Guthrie Tests, 2003, available online, http://www.privacy.org.nz/library/guthrie-tests, accessed 6 October 2006 Proposed International Guidelines on International Issues in Medical Genetics and Genetic
Services, WHO/HGN/GL/ETH/981 (World Health Organisation, Geneva, 1998) (WHO No1) Wertz, Dorothy C, Fletcher, J C, and Berg, K, Review of Ethical Issues in Medical Genetics:
Report of Consultant to WHO, WHO/HGN/ETH/00.4 (World Health Organisation, Geneva, 2003) (WHO No2)
Internet Resources Auckland District Health Board website, Newborn Services Clinical Guidelines, available at http://www.adhb.govt.nz/newborn/Guidelines/Nutrition/MetabolicScreening.htm, accessed 3 October 2006 Donnellan, Eithne, “Woman in Court Transfusion Case Recovering in Hospital” The Irish
Times, 22 September 2006, online at http://www.ireland.com/newspaper/front/2006/0922/ 115859088 1290.html accessed 7 October 2006 Health and Disability Commissioner, Guthrie Tests and Informed Consent Issues http://www.hdc.org.nz/publications/articles?Guthrie%20tests%20and%20informed%20consent%20issues accessed 5 October 2006 Human Genetics Society of Australasia, Mission Statement, online at http://hgsa.com.au/Index.cfm?pid=111125 accessed 7 October 2006 Post-polio Support Society website, online at http://www.everybody.co.nz/page-c96b6b4a-fa1a-4c46-9672-e05c8a4a5376.aspx accessed 7 October 2006 LabPLUS, Auckland District Health Board, National Testing Centre, online at http://www.labplus.co.nz/nationaltest.htm accessed 6 October 2006 Ministry of Health Website, National Screening Unit, Conditions Tested, available online at http://www.moh.govt.nz/moh.nsf/238fd5fb4fd051844c256669006aed57/1cc77940747fe4a7cc2570c0 000c061c?OpenDocument, accessed 4 October 2006
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Ministry of Health website, National Screening Unit, Newborn Screening in New Zealand
Today, online at http://www.moh.govt.nz/moh.nsf/238fd5fb4fd051844c256669006aed57/38 a4fd0fef7aa870cc2570c0000bffef?OpenDocument, accessed 4 October 2006 National Testing Centre, Your Newborn Baby's Blood Test: Te Whakamātau Toto O To Peepi
Hōu, National Testing Centre, Ministry of Health, Auckland, 2004, online at file:///C:/Documents%20and%20Settings/Acer/My%20Documents/Dissertation/Chapter%20One/Newborn%20screening%20leaflet%20NZ.htm accessed 5 October 2006 Pediatrix Screening website, Pediatric Medical Group, Tandem Mass Spectrometry at http://www.pediatrix.com/body_screening.cfm?id=343 accessed 6 October 2006 South Dakota Department of Health Newborn Screening Programme, Newborn Screening,
Tests That Could Save Your Baby’s Life, South Dakota Department of Health, 2005, online at http://www.state.sd.us/doh/NewbornScreening/index.htm accessed 5 October 2006 South Dakota Department of Health Newborn Screening Programme, South Dakota Newborn
Metabolic Screening Practitioners Manual, South Dakota Department of Health, 2005, online at http://www.state.sd.us/doh/NewbornScreening/NMS_Guide.pdf accessed 5 October 2006
Other
Memorandum of Understanding between the Ministry of Health and the New Zealand Police
relating to the disclosure of newborn blood spot samples and related information, in effect since 28 February 2006 Diane Webster, Director, National Testing Centre. Correspondence via telephone and email on July 17 2006 and 5 October 2006.
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Appendix One: Table of Disorders Tested for By Newborn Screening in New Zealand